Overview
Sponsor-declared trial summary
Sarcoma
• To evaluate clinical efficacy of Ris-Rez in participants with unresectable Relapsed/refractory (R/R) Osteosarcoma (OSA) (Cohort 1) who have progressed after or are intolerant to at least one prior line of systemic therapy. • To evaluate clinical efficacy of Ris-Rez in participants with unresectable advanced or metas…
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-05-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
• To evaluate clinical efficacy of Ris-Rez in participants with unresectable Relapsed/refractory (R/R) Osteosarcoma (OSA) (Cohort 1) who have progressed after or are intolerant to at least one prior line of systemic therapy.
• To evaluate clinical efficacy of Ris-Rez in participants with unresectable advanced or metastatic Soft tissue sarcoma (STS) (Cohort 2) who have progressed after or are intolerant to at least one prior line of systemic therapy.
Conditions and MedDRA coding
Sarcoma
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- • Participants must be ≥ 12 years of age.
- • Has histologically confirmed unresectable advanced or metastatic R/R OSA (Cohort 1) or unresectable advanced or metastatic STS (Cohort 2) that has progressed to at least one prior line of systemic therapy.
- • Has documented disease progression on the last line of systemic treatment as confirmed by radiological imaging.
- Has an ECOG performance status of 0 or 1, or Lansky PS/Karnofsky PS ≥ 70% for adolescent participants, with no deterioration in the 2 weeks prior to first dose/randomization.
- • Has adequate organ function.
- • All participants, or their legal guardians, must provide signed informed consent and agree to follow the study protocol before starting any study activities
Exclusion criteria 7
- • Has received any prior therapy with an Antibody-drugconjugates (ADC) with a TOPO1-inhibitor payload.
- "• Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study."
- • Has severe, uncontrolled or active cardiovascular disorders.
- • Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
- "• Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases."
- • Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention.
- • Is pregnant or breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Progression free survival rate at week18 (PFS18) assessed by the investigator as per RECIST 1.1.
- Confirmed ORR, defined as the proportion of participants who have achieved a confirmed CR or PR as assessed by investigator, according to RECIST 1.1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
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
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 5
| Organisation | City, country | Duties |
|---|---|---|
| Medable Inc. ORG-100043083
|
Palo Alto, United States | E-data capture |
| Teckro Limited ORG-100041454
|
Limerick, Ireland | Code 2 |
| F-M Richard Et Associes ORG-100042723
|
Levallois-Perret, France | Other |
| Iqvia Laboratories Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 14 | 3 |
| Rest of world
Canada, United States, Israel, United Kingdom, Japan
|
— | 54 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523997-18-00_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient Facing Material_PRO_Redaction Statement | NA |
| Protocol (for publication) | D4_Subject card_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure __No CCI PI | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF _adult_cohort 2_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF _children 12 to 17 years old_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF _parents or parental authority holders_cohort 2_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF adult_cohort 1_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF_parents or parental authority holders_cohort 1_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Restart Master treatment beyond disease progression_No CCI PI | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ Restart after liver event _No CCI PI | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnancy participant_No CCI PI | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_pregnancy partner_No CCI PI | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2025-523997-18-00_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2025-523997-18-00_Redacted_FR | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-21 | France | Acceptable 2026-05-22
|
2026-05-27 |