BOLD-100 combined with FOLFOX for advanced solid tumors

A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

This study is testing if a new drug called BOLD-100 can work better with FOLFOX chemotherapy for people with advanced solid tumors like colorectal and pancreatic cancers.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bold Therapeutics, Inc. (Industry-sponsored)
• Drugs / interventions: radiation, chemotherapy
• Locations: 18 sites (Santa Monica, California and 17 other locations)
• Trial ID: NCT04421820 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of BOLD-100, a ruthenium-based small molecule, when used in combination with FOLFOX chemotherapy for patients with advanced solid tumors, including colorectal, pancreatic, gastric cancers, and cholangiocarcinoma. The study consists of a dose escalation phase to assess safety and tolerability, followed by a cohort expansion phase to further evaluate the treatment's efficacy. Participants will have previously received at least one line of chemotherapy and will be monitored for responses to the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with metastatic or unresectable gastrointestinal tumors who have received prior chemotherapy.

Not a fit: Patients with early-stage tumors that are resectable or those who have not received prior chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While the combination of BOLD-100 with FOLFOX is a novel approach, similar studies using targeted therapies in combination with chemotherapy have shown promising results in treating advanced cancers.

Eligibility criteria

Inclusion Criteria:

1. Be 18 years or older.
2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
3. Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable. (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting.
4. Have measurable disease according to RECIST v1.1.
5. Have an anticipated survival of at least 16 weeks.
6. Be ambulatory, with an ECOG performance score of 0 or 1.
7. Have adequate organ function.
8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion.
9. Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF).
10. (ARM VII): BRAF wild-type tumour status.

Exclusion Criteria:

1. Neuropathy \> grade 2
2. Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin.
3. Cerebrovascular accident within the past 6 months before the start of treatment.
4. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
5. Any serious medical conditions that might be aggravated by treatment or limit compliance.
6. Any history of serious cardiac illness.
7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment.
8. Any other known malignancy within 3 years before the start of treatment.
9. Active gastrointestinal tract disease with malabsorption syndrome.
10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
11. Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment.
12. Recent history of weight loss \> 10% of current body weight in past 3 months before the start of treatment.
13. HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
14. Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
15. Currently breastfeeding
16. Dihydropyrimidine Dehydrogenase (DPD) deficiency
17. Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
18. (ARM VII): Prior exposure to BOLD-100
19. (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours
20. (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)

Where this trial is running

Santa Monica, California and 17 other locations

• University of California, Los Angeles — Santa Monica, California, United States (Completed)
• Moffitt Cancer Center — Tampa, Florida, United States (Completed)
• Cross Cancer Institue — Edmonton, Alberta, Canada (Recruiting)
• Juravinski Cancer Centre — Hamilton, Ontario, Canada (Recruiting)
• The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (Recruiting)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
• Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
• McGill University Health Centre Glen Site — Montreal, Quebec, Canada (Recruiting)
• Universitatsklinikum Bonn — Bonn, Germany (Recruiting)
• University Hospital of Ulm — Ulm, Germany (Recruiting)
• Mater Miserecordiae University Hospital — Dublin, Ireland (Recruiting)
• St. James Hospital — Dublin, Ireland (Recruiting)
• St. Vincent's University Hospital — Dublin, Ireland (Recruiting)
• National Cancer Center — Goyang, South Korea (Recruiting)
• Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Severance Hospital - Yonsei University — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Michelle Jones

Conditions Colorectal Cancer; Pancreatic Cancer; Gastric Cancers; Cholangiocarcinoma