OncoMatch/Clinical Trials/NCT04421820
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Is NCT04421820 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including BOLD-100 +/- FOLFOX Chemotherapy (Arm VII) and BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) for colorectal cancer.
Treatment: BOLD-100 +/- FOLFOX Chemotherapy (Arm VII) · BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Pancreatic Cancer
Cholangiocarcinoma
Biomarker criteria
Required: BRAF wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: fluorouracil
Previous intolerance to or significant reaction secondary to fluorouracil
Cannot have received: oxaliplatin
Previous intolerance to or significant reaction secondary to ... oxaliplatin
Cannot have received: radiation therapy
Treatment with radiation therapy ... within 4 weeks prior to starting treatment.
Cannot have received: surgery
Treatment with ... surgery within 4 weeks prior to starting treatment.
Cannot have received: investigational therapy
Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
Cannot have received: anti-cancer therapy
Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
Cannot have received: BOLD-100 (BOLD-100)
(ARM VII): Prior exposure to BOLD-100
Cannot have received: monoclonal antibody therapy (anti-EGFR, anti-VEGF, anti-HER2)
(ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
Cannot have received: potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, Los Angeles · Santa Monica, California
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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