BOLD-100 in Combination with FOLFOX for the Treatment of Advanced Solid Tumours

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bold Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Jul 2025 → ongoing

Decision date (initial)

2026-02-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bold Therapeutics Inc.

External identifiers

EU CT number

2024-517500-11-00

EudraCT number

2022-003079-41

ClinicalTrials.gov

NCT04421820

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Dose response, Safety, Therapy, Pharmacodynamic

PART A (Dose Escalation):
To assess the safety, tolerability and Maximum Tolerated Dose (MTD) of FOLFOX standard-of-care (FOLFOX SOC) combination chemotherapy + BOLD-100 in advanced solid tumours.

PART B (Dose Expansion Phase):
To assess response rates to SOC combination chemotherapy + BOLD-100 in advanced solid tumours.

Conditions and MedDRA coding

Colorectal Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Be 18 years or older.
2. Able to take oral medications (for pre-medications and supportive management).
3. Understand and be able, willing, and likely to fully comply with study procedures and restrictions.
4. Be fully informed about their illness and the investigational nature of the study protocol, and sign an approved Informed Consent Form (ICF).
5. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
6. Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX as standard of care per investigator judgement. Participants will have received at least one line of chemotherapy in the metastatic setting (in the dose escalation phase only). For the dose expansion phase, the setting will vary based on the malignancy. Colorectal cancer: Patients must have received at least 1 prior line of therapy prior to enrollment in this study. Pancreatic cancer: Patients must have received at least 1 prior line of therapy. Gastric cancer: Patients who have not received prior treatment may be included in this study. Cholangiocarcinoma: Patients must have received at least 1 prior line of therapy (with gemcitabine-based chemotherapy). Colorectal cancer (ARM VI): Patients must have received at least 2 prior lines of therapy prior to enrollment in this study, one of which was a 5-FU based regimen. Colorectal cancer (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting prior to erollment in this study. Prior oxaliplatin therapy is permitted in the following two situations: 1. patients who have received oxaliplatin in the adjuvant setting. 2. patients who have received oxaliplatin in the first line metastatic setting but did not progress on treatment or within 3 months of oxaliplatin treatment cessation.
7. Have measurable disease according to RECIST v1.1 (at least one measurable lesion).
8. Have an anticipated survival of at least 16 weeks.
9. Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
10. Have adequate organ function, defined as: - Hematologic: ANC ≥ 1.5 x 109/L, Hgb ≥ 9.0 g/dL and platelet count ≥ 100 x 109/L - Hepatic: total bilirubin ≤ 1.5 x ULN; transaminases ≤ 2.5 x ULN (may be up to 5 x ULN if clearly due to liver metastases), ALP ≤ 2.5 x ULN - Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min. - Urine protein is 0, trace, or +1 on dipstick urinalysis, or < 1.0 gram on 24-hour urine protein analysis.
11. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion (e.g., non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates, diphenylhydantoin, narcotic analgesics, probenecid). Such drugs may be initiated while the subject is participating in this study.
12. Resolved acute effects of any prior therapy to baseline severity or grade ≤1 CTCAE 5.0 except for adverse events not constituting a safety risk by investigator judgment (such as alopecia).
13. (ARM VII): BRAF wild-type tumour status.

Exclusion criteria 23

1. Neuropathy > grade 2
2. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
3. Treatment with radiation therapy or surgery within 1 month prior to study entry.
4. Recent history of weight loss > 10% of current body weight in past 3 months.
5. Current (within 1 week of the start of the study) or regular use of any medication (including OTC, herbal or homeopathic preparations) that could affect (improve or worsen) the cancer being studied, or could affect the action or disposition of BOLD-100, or its clinical or laboratory assessment, e.g., Coumadin therapy, due to high competitive protein binding. Subjects taking ANY supplemental IRON, i.e., therapeutic or as part of a multivitamin regimen, are excluded from this study, whether prescribed or self-medicated.
6. HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
7. Any condition potentially decreasing compliance to study procedures. Concurrent use of another investigational therapy or anti-cancer therapy.
8. Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
9. Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin
10. (ARM VII): Prior exposure to BOLD-100
11. (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours
12. (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
13. Cerebrovascular accident within the past 6 months.
14. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam.
15. Any serious medical conditions that might be aggravated by treatment or limit compliance. This includes, but is not limited to uncontrolled psychiatric disorders, serious infections, active peptic ulcer disease and bleeding diathesis
16. Any history of serious cardiac illness including (but not confined to): o Previous or active myocardial infarction < 6 months o Congestive cardiac failure (NYHA III or IV) o History of unstable angina pectoris < 6 months o Recent coronary artery bypass grafting < 6 months o Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) o Ventricular arrhythmia < 6 months o Left ventricular ejection fraction (LVEF) < 50% as measured either by radionuclide angiography or echocardiogram o QTc interval > 470 msec
17. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months.
18. Any other known malignancy within 3 years before the start of treatment (with the exception of non-melanoma skin cancer that had undergone curative treatment, cervical cancer in situ, or ductal/lobular carcinoma in situ of the breast that has underwent local treatment.
19. Active gastrointestinal tract disease with malabsorption syndrome.
20. (ARM VII): Patients considered resitant to Oxaliplatin: Patients who have received oxaliplatin in the adjuvat setting who have progressed / relapsed within 6 months of their last oxaliplatin administration. Patients with advanced colorectal cancer who have progressed (based on RECIST 1.1) while on or within 3 months of their last administration of oxaliplatin.
21. Currently breastfeeding
22. Dihydropyrimidine Dehydrogenase (DPD) deficiency (Note: when tested/required prior to administration of 5-fluorouracil (5-FU) as per Principal Investigator’s best medical judgement and based on the local practice guidelines and 5-FU local prescribing instructions. In the EU, DPD testing is required, while in other countries it may be recommended).
23. Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0;
2. Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;
3. Incidence of dose-limiting toxicities (DLT);
4. Clinically significant changes from baseline in: - Laboratory evaluations (chemistry, hematology, coagulation, urinalysis); - Electrocardiograms; - Vital signs; - Physical examinations; - Eastern Cooperative Oncology Group (ECOG) performance status
5. Progression Free Survival (PFS)
6. Overall Response Rate (ORR)
7. Overall Survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bold Therapeutics Inc.

Sponsor organisation

Bold Therapeutics Inc.

Address

422 Richards Street Suite 170

City

Vancouver

Postcode

V6B 2Z4

Country

Canada

Scientific contact point

Organisation

Bold Therapeutics Inc.

Contact name

Bold Clinical Trial Information

Public contact point

Organisation

Bold Therapeutics Inc.

Contact name

Bold Clinical Trial Information

Third parties 4

Locations

4 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications