Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
72
Countries
1
Sites
5
Neoplasms
To determine the MTD/MAD and evaluate the safety and tolerability of GSK5764227 when administered in combination with SoC in participants with advanced solid tumors.
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- GlaxoSmithKline Research & Development Limited
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacokinetic
To determine the MTD/MAD and evaluate the safety and tolerability of GSK5764227 when administered in combination with SoC in participants with advanced solid tumors.
Secondary objectives 3
- To describe the exposure to GSK5764227 following IV infusion administration when administered in combination with SoC in participants with advanced solid tumors.
- To evaluate the immunogenicity of GSK5764227 when administered in combination with SoC in participants with advanced solid tumors.
- To evaluate the clinical activity of GSK5764227 when administered in combination with SoC in participants with advanced solid tumors.
Conditions and MedDRA coding
Neoplasms
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
- Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
- Has adequate organ function.
- Cohort A: Has histologically confirmed unresectable adenocarcinoma or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by WHO classification).
- Cohort A: Must have received at least 1 and no more than 2 lines of systemic treatment for advanced CRC, with documented progression on most recent prior line of therapy Prior lines of therapy must have included treatment with either a fluoropyrimidine, oxaliplatin and/or irinotecan, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody, if the approved biologic therapy(ies) is available. In addition, per local practice guidelines, qualifies for treatment with Bevacizumab and/or 5-FU/LV. • Participants with dMMR/MSI-H status may be eligible if they have received prior ICI therapy (if an approved ICI(s) is available) and also meet all other criteria related to prior therapies as listed above. • Participants with known targetable genomic aberrations may be eligible if they meet all other criteria related to prior therapies as listed above and have received the following (if the approved biomarker-directed therapy/-ies is/are available): • KRAS G12C mutation, e.g., adagrasib or sotorasib • BRAF V600E mutation, e.g., encorafenib • HER2 amplification, e.g., trastuzumab with another agent (NOTE: participants who received treatment with T-DX1 are excluded) • Participants who received neoadjuvant or adjuvant chemotherapy and experienced disease progression during treatment or within 6 months of the EOT may count this therapy as a line of treatment.
- Cohort A: Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. Measurable lesions that have been previously irradiated and have been shown to be progressing following irradiation may be considered as target lesions. NOTE: It is preferable not to have a pathological lymph node as a singular target lesion.
- Cohort A: Participants must provide tissue from a biopsy taken from primary cancer or metastatic site. Fresh biopsy is preferred. If a fresh biopsy is not feasible, archival FFPE blocks (preferred) or slides from the most recent biopsy are acceptable (preferably taken after the completion of the participant’s last line of therapy prior to the first dose of study drug). Tissue is required for retrospective B7-H3 expression analysis by IHC and other biomarker evaluations. Exceptions may be granted by the medical monitor if tissue is unavailable.
- Cohort B: Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Cohort B: Metastatic (stage IVB) disease, excluding participants with metastatic disease restricted to pelvic lymph nodes or rectum.
- Cohort B: PSA ≥ 1 ng/mL during the screening period.
- Cohort B: Serum testosterone level ≤ 50 ng/dL or 1.7 nmol/L during the screening period. Patients must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a GnRH agonist or antagonist; this therapy must have been initiated at least 4 weeks prior to randomization and treatment must be continued throughout the study.
- Cohort B: Progression on or intolerance to SoC lines of therapy in the mCRPC stage [including, but not limited to, docetaxel, ARPI/ novel hormone therapies (such as enzalutamide, apalutamide, darolutamide), and radio-ligand therapy, etc.]. Participants who have experienced disease progression while receiving NHA in mHSPC are allowed. • If the participant is intolerant to NHA, refuses it, or cannot receive it for other reasons, they may be eligible if they have experienced disease progression after receiving at least one systemic chemotherapy regimen. • First-generation antiandrogen therapy (i.e., bicalutamide, flutamide, nilutamide) are not considered a novel hormonal agent or a chemotherapy regimen. Participants who have taken first-generation antiandrogen therapeutic drugs must have a washout period of at least 28 days before enrolment. • Progressive disease is defined as (at least one of the following): • PSA progression: PSA > 1 ng/mL and 2 consecutive increases in PSA at least 1 week apart (compared to current treatment baseline or the nadir during the treatment period) per PCWG3 criteria; and/or • Progression of soft tissue lesions according to RECIST 1.1 criteria; and/or • Bone lesion progression according to PCWG3 criteria.
- Cohort B: Has metastatic prostate cancer that includes: ≥1 measurable soft tissue per RECIST 1.1 (not including regional Lymph Nodes) and/or ≥1 metastatic bone lesion per PCWG3 criteria (not a superscan) on bone scintigraphy, at screening.
- Cohort B: Where available, participants should provide an archival tumor sample from the most recent biopsy (FFPE block preferred) of primary cancer or from a metastatic site at screening (preferably taken after the completion of the participant’s last line of therapy prior to the first dose of study drug).
Exclusion criteria 21
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of disease.
- Has had any major surgery within 28 days prior to first dose.
- Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
- Has serious infection within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with IV antibiotics for ≥2 weeks; active infections with therapeutic IV antibiotics within 2 weeks prior to the first dose. Participants who are receiving or have received prophylactic antibiotics (e.g., prophylaxis against urinary infections) are allowed.
- Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for at least 4 weeks prior to dosing are not excluded from participation.
- Any evidence of current ILD or pneumonitis OR a prior history of ILD requiring high-dose glucocorticoids or non infectious pneumonitis requiring high-dose glucocorticoids.
- Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).
- Has received any prior therapy with an ADC with a TOPO1-inhibitor payload.
- Cohort A: History of abdominal or gastrointestinal fistula, tracheoesophageal fistula or any Grade 4 fistula, gastrointestinal perforation, or intra‑abdominal abscess or active clinical concern for bowel obstruction.
- Cohort A: Serious non-healing wound, non-healing ulcer or non-healing bone fracture. Note: If the participant has had surgery, the wound must be fully healed prior to first dosing.
- Cohort A: Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia.
- Cohort A: Has a history of nephrotic syndrome or Grade 3 proteinuria. Participants discovered to have ≥2 proteinuria on at screening should undergo a 24 hour urine collection and must demonstrate ≤1 g of protein in 24 hours to be eligible.
- Cohort A: Known coagulopathy that increases risk of bleeding, bleeding diatheses. Any other hemorrhage/bleeding event CTCAE grade ≥ 3 within 4 weeks prior to first dosing.
- Cohort A: Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to first dosing.
- Cohort A: Deep venous thromboembolic event within 3 months prior to first dosing or any previous NCI CTCAE grade 4 venous thromboembolism.
- Has known complete DPD deficiency (Cohort A2 only).
- Principal Exclusion Criteria Cohort A: Has received treatment with any of the following within the specified timeframe prior to the first dose of study drug: • Strong or moderate inhibitors of CYP3A4, CYP2D6, or inhibitors of P-gp or BCRP, within 7 days prior to the first dose of study drug. • Strong or moderate inducers of CYP3A4 or inducers of P-gp, within 14 days prior to the first dose of study drug.
- Cohort B: Has serious arteriovenous thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.) within 3 months prior to the first dose (except for implantable venous port, catheter-related thrombosis, or superficial vein thrombosis, which are not considered "serious" (thromboembolism).
- Cohort B: Has serious or poorly controlled hypertension, including: history of hypertensive crisis, hypertensive encephalopathy; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose; or recurrent systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during Screening period
- Cohort B: Has a history of nephrotic syndrome or Grade 3 proteinuria. Participants discovered to have ≥2 proteinuria on dipstick at screening should undergo a 24 hour urine collection and must demonstrate <2 g of protein in 24 hours to be eligible.
- Cohort B: Has received treatment with any of the following within the specified timeframe prior to the first dose of study drug: • Strong or moderate inhibitors of CYP3A4, CYP2D6, or strong inhibitors of CYP2C8, or inhibitors of P-gp or BCRP, within 7 days prior to the first dose of study drug. • Strong or moderate inducers of CYP3A4 (except enzalutamide) or inducers of P-gp, within 14 days prior to the first dose of study drug. • CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, within 7 days prior to the first dose of enzalutamide.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of AEs using NCI-CTCAE v5.0, including DLTs and change in safety parameters: • Incidence and severity of AEs/SAEs/AESIs and AEs leading to dose modifications • Vital signs, body weight, laboratory tests (hematology, clinical chemistry, urinalysis), cardiac function (ECG), and ECOG performance status changes
Secondary endpoints 8
- Observed PK concentrations of GSK5764227 (conjugated antibody) and GSK5757810 (payload).
- ADA and NAb incidence and ADA titers against GSK5764227
- ORR, defined as the proportion of participants who have achieved BOR of confirmed CR or PR as assessed by investigator, according to RECIST 1.1 (Cohort A) or per PCWG3 (Cohort B).
- DCR18, defined as the proportion of participants who have achieved CR or PR, or SD of ≥17 weeks as assessed by investigator according to PCWG3 (Cohort B).
- DoR, defined as the time from the date of the first documented objective response (CR/PR) as assessed by investigator according to RECIST 1.1 (Cohort A) or PCWG3 (Cohort B), until the date of the first documented PD or death due to any cause, whichever is earlier
- PFS defined as the time from the date of first dose until the earliest date of documented disease progression as assessed by investigator according to RECIST 1.1 (Cohort A)
- rPFS (Cohort B): defined as the time from the date of first dose until the earliest date of documented PD per PCWG3-modified RECIST 1.1 (soft tissue lesion assessment) and/or PCWG3 bone lesion assessment (Cohort B)] or death due to any cause.
- PSA50 response defined as a ≥50% decline in PSA levels from baseline (Cohort B)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
Xtandi - 40 mg film-coated tablets
PRD5515466 · Product
- Active substance
- Enzalutamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L02BB04 — -
- Marketing authorisation
- EU/1/13/846/002
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided Xtandi (Enzalutamide) - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The Xtandi (Enzalutamide) - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
Calciumfolinat Kabi 10 mg/ml Injektions-/Infusionslösung
PRD11849766 · Product
- Active substance
- Folinic Acid
- Substance synonyms
- LEUCOVORIN
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- 93327.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided Folinic Acid - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The Folinic Acid - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
5-FLUOROURACILEBEWE, 50 Mg/Ml, Roztwór Do Wstrzykiwan I Infuzji
PRD12067114 · Product
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 4506
- MA holder
- EBEWE PHARMA
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided 5-Flurouracil - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The 5-Flurouracil - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
Bendafolin 10 mg/ml Injektionslösung
PRD12109806 · Product
- Active substance
- Folinic Acid
- Substance synonyms
- LEUCOVORIN
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- 44048.05.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided Folinic Acid - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The Folinic Acid - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
5-FU medac 50 mg/ml, Injektionslösung
PRD536079 · Product
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 41196.00.00
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided 5-Flurouracil - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The 5-Flurouracil - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
BENDAFOLIN 10 mg/ml Injektionslösung
PRD12109804 · Product
- Active substance
- Folinic Acid
- Substance synonyms
- LEUCOVORIN
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- 44048.05.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided Folinic Acid - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The Folinic Acid - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
Zirabev 25 mg/ml concentrate for solution for infusion
PRD7082676 · Product
- Active substance
- Bevacizumab
- Substance synonyms
- BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/18/1344/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided Zirabev (Bevacizumab) - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The Zirabev (Bevacizumab) - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
5-Флуороурацил Ебеве 50 mg/ml концентрат за инжекционен и инфузионен разтвор.
PRD12087772 · Product
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 20000369
- MA holder
- EBEWE PHARMA
- MA country
- Bulgaria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided 5-Flurouracil - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The 5-Flurouracil - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
PRD11337463 · Product
- Active substance
- GSK5764227
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Benda-5 FU 50 mg/ml Injektionslösung
PRD12026901 · Product
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 55983.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided 5-Flurouracil - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The 5-Flurouracil - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
Zirabev 25 mg/ml concentrate for solution for infusion
PRD7082765 · Product
- Active substance
- Bevacizumab
- Substance synonyms
- BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/18/1344/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The commercial product is Secondary Packaged and Labeled and QP Released at the manufacturing sites identified within Section 2.1.P.3.1 of the provided Zirabev (Bevacizumab) - sIMPD. Secondary Packaging and Labeling is conducted at the following (4) sites: (1.) GlaxoSmithKline Research & Development Limited Third Avenue, Harlow, CM19 5AW, United Kingdom (2.) GlaxoSmithKline LLC 1011 North Arendell Avenue, Zebulon, North Carolina, 27597, United States (3.) Almac Clinical Services Limited Seagoe Industrial Estate, 9 Charlestown Road, Craigavon, BT63 5PW, United Kingdom (4.) Almac Clinical Services 25 Fretz Road, Souderton, PA, 18964 United States QP Release was conducted at the following site: GlaxoSmithKline Research & Development Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland The Zirabev (Bevacizumab) - QP Declaration is provided from GlaxoSmithKline Research & Development Limited (Dublin, IRL). MIA is provided for GlaxoSmithKline Research & Development Limited (Dublin, IRL).
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- 79 New Oxford Street
- City
- London
- Postcode
- WC1A 1DG
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Teckro Limited ORG-100041454
|
Limerick, Ireland | Other |
| Infinity Biologix LLC ORG-100040369
|
Piscataway, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Laboratory analysis |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Laboratory analysis |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Primera Analytical Solutions Corp. ORG-100040944
|
Cranbury, United States | Laboratory analysis |
| Sermes CRO ORG-100030576
|
Madrid, Spain | Other |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 15 | 5 |
| Rest of world
Korea, Republic of, Canada, United Kingdom, United States, Australia
|
— | 57 | — |
Investigational sites
Hospital Universitario Virgen De La Victoria
Oncología, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitari Vall D Hebron
Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncología, Calle Ona 10, 28050, Madrid
Hospital Universitario Ramon Y Cajal
Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-12-03 | 2025-12-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522274-37-00_redacted | 1 |
| Protocol (for publication) | D4_Subject card | 1 |
| Protocol (for publication) | D4_Subject card_ES_es | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedure | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_List of adverse effects of other drugs Cohort A | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Dose Escalation-Cohort A_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Dose Escalation-Cohort B_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_Treatment After Progression_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Treatment Restart_no related | 3.0 |
| Subject information and informed consent form (for publication) | LL1_ICF_Pregnant Participant or Partner_redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Bevacizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Bevacizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Enzalutamide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Fluorouracil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Fluorouracil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Fluorouracil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Fluorouracil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Folinic acid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Folinic acid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC_Folinic acid | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522274-37-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522274-37-00_ES_es | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-22 | Spain | Acceptable 2025-11-19
|
2025-11-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-16 | Spain | Acceptable 2026-05-11
|
2026-05-18 |