BOLD-100 with FOLFOX for Advanced Gastrointestinal Cancers
This study is testing BOLD-100, a new drug, in combination with standard FOLFOX chemotherapy for advanced gastrointestinal cancers like colorectal, pancreatic, gastric cancers, and cholangiocarcinoma. BOLD-100 works by decreasing a protein called GRP78 in cancer cells. The study aims to find the safest and most effective dose of BOLD-100 when given with FOLFOX. You might be able to join if you are 18 or older and have certain types of advanced gastrointestinal tumors. For colorectal cancer, you must have had only one prior treatment for metastatic disease and not received oxaliplatin. The main goals are to track any side effects and how well the treatment is tolerated. Enrollment in some parts of the study (Arms I-VI) is closed, but Arm VII, specifically for colorectal cancer, is still enrolling participants.
- Study design
- This is a multi-center, non-randomized study, but Arm VII for colorectal cancer will randomize participants to receive one of two doses of BOLD-100 plus FOLFOX, or FOLFOX alone, in a 1:1:1 ratio. The study plans to enroll 220 participants.
- What's involved
- Participants will receive BOLD-100 combined with FOLFOX chemotherapy. You will undergo physical exams, ECGs (heart tests), vital sign checks, and lab tests throughout the study and for about two weeks after your last treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed through study completion, which is approximately two weeks after your last treatment, to monitor for side effects and other health changes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
At a glance
Conditions
Where it's being run
24 sites across 10 statesWho to contact
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What this trial measures
- Incidence and severity of adverse events ([S]AEs)Through study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
- Incidence of dose-limiting toxicities (DLT)Screening to 4 weeks after first treatment
Dose escalation only.
- Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results, ECOG performance statusThrough study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
- Progression Free Survival (PFS): Arm VIIThrough study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
- Overall Response Rate (ORR): Arm VIIThrough study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
- Overall Survival (OS): Arm VIIThrough study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure