BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours
Bold Therapeutics, Inc.
220 participants
Aug 28, 2020
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria10
- Be 18 years or older.
- Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
- 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.
- Have measurable disease according to RECIST v1.1.
- Have an anticipated survival of at least 16 weeks.
- Be ambulatory, with an ECOG performance score of 0 or 1.
- Have adequate organ function.
- Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion.
- Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF).
- (ARM VII): BRAF wild-type tumour status.
Exclusion Criteria20
- Neuropathy \> grade 2
- Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin.
- Cerebrovascular accident within the past 6 months before the start of treatment.
- History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
- Any serious medical conditions that might be aggravated by treatment or limit compliance.
- Any history of serious cardiac illness.
- Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment.
- Any other known malignancy within 3 years before the start of treatment.
- Active gastrointestinal tract disease with malabsorption syndrome.
- Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
- Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment.
- Recent history of weight loss \> 10% of current body weight in past 3 months before the start of treatment.
- HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
- Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
- Currently breastfeeding
- Dihydropyrimidine Dehydrogenase (DPD) deficiency
- Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
- (ARM VII): Prior exposure to BOLD-100
- (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours
- (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
Interventions
Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone
BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT04421820