A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours
Bold Therapeutics, Inc.
Summary
BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.
Description
BOLD-100 is a novel, targeted anti-cancer therapy which is an intravenously administered small molecule drug. In a previous Phase 1 study (NCT01415297) BOLD-100 showed low toxicity with minimal hematological issues as well as some potential anti-tumour activity. The lack of observed hematological toxicity and neurotoxicity position BOLD-100 well for use in combination with a broad range of standard-of-care (SOC) chemotherapy regimens. This is a prospective, multicenter non-randomized Phase 1b/2a dose escalation \& expanded cohort study of BOLD-100 in patients with advanced gastrointestinal ma…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 drug…
Interventions
- DrugBOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone
- DrugBOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
Locations (18)
- University of California, Los AngelesSanta Monica, California
- Moffitt Cancer CenterTampa, Florida
- Cross Cancer InstitueEdmonton, Alberta
- Juravinski Cancer CentreHamilton, Ontario
- The Ottawa Hospital Cancer CentreOttawa, Ontario
- Princess Margaret Cancer CentreToronto, Ontario