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Small Molecule

BOLD-100 + FOLFOX for Advanced Cancers

Phase 1 & 2
Waitlist Available
Research Sponsored by Bold Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 years or older
Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to study discontinuation (an average of 2 months)
Awards & highlights

Study Summary

This trial will test the safety of a new ruthenium-based drug, BOLD-100, when combined with a standard chemotherapy regimen. The drug will be given intravenously, and the trial will first assess safety in a small group of patients before expanding to a larger group.

Who is the study for?
Adults with certain advanced solid tumors (pancreatic, stomach, bile duct, colorectal) who've had previous chemotherapy can join this trial. They must be expected to live at least 16 weeks, have measurable disease, good organ function and performance status. Pregnant women and those with serious medical conditions or recent surgeries are excluded.Check my eligibility
What is being tested?
The trial is testing BOLD-100 combined with FOLFOX chemotherapy in patients with specific gastrointestinal cancers. It starts by slowly increasing the dose to find a safe level before giving it to more people to see how well it works.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion of BOLD-100 or FOLFOX such as nausea, fatigue, blood count changes, nerve damage (neuropathy), and allergic reactions. Organ-specific inflammation might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can move around and my health is good enough for most activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to study discontinuation (an average of 2 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to study discontinuation (an average of 2 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results (chemistry, hematology, coagulation, urinalysis), Eastern Cooperative Oncology Group (ECOG) performance status
Incidence of dose-limiting toxicities (DLT)
+1 more
Secondary outcome measures
Baseline GRP78 biomarker levels (Counts/mL)
Changes in GRP78 biomarker levels during treatment (Counts/mL)
Progression Free Survival (PFS); Overall Response Rate (ORR); Overall Survival (OS)
+5 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)Experimental Treatment1 Intervention
Open to enrollment.
Group II: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group III: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)Experimental Treatment1 Intervention
Open to enrollment.
Group IV: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group V: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group VI: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)Experimental Treatment1 Intervention
Arm closed to enrollment.
Group VII: Part A - Dose Escalation - Pancreatic CancerExperimental Treatment1 Intervention
Arm closed to enrollment.
Group VIII: Part A - Dose Escalation - Gastric CancerExperimental Treatment1 Intervention
Arm closed to enrollment.
Group IX: Part A - Dose Escalation - Colorectal CancerExperimental Treatment1 Intervention
Arm closed to enrollment.
Group X: Part A - Dose Escalation - CholangiocarcinomaExperimental Treatment1 Intervention
Arm closed to enrollment.

Find a Location

Who is running the clinical trial?

Bold Therapeutics, Inc.Lead Sponsor

Media Library

BOLD-100 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04421820 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Part B - Dose Expansion - 1L Gastric Cancer (ARM I), Part B - Dose Expansion - 2L Gastric Cancer (ARM II), Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III), Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV), Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI), Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V), Part A - Dose Escalation - Gastric Cancer, Part A - Dose Escalation - Pancreatic Cancer, Part A - Dose Escalation - Colorectal Cancer, Part A - Dose Escalation - Cholangiocarcinoma
Colorectal Cancer Clinical Trial 2023: BOLD-100 Highlights & Side Effects. Trial Name: NCT04421820 — Phase 1 & 2
BOLD-100 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04421820 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients still being enrolled in this clinical trial?

"The latest information available on clinicaltrials.gov suggests that this trial is still open to patients. The listing was first posted on 8/28/2020 and has been edited as recently as 11/7/2022."

Answered by AI

Is this trial being overseen by more than one organization?

"Currently, patients are being enrolled at University of California, Los Angeles in Santa Monica, California; Cross Cancer Institue in Edmonton, Alberta; McGill University Health Centre Glen Site in Montréal, Quebec as well as 8 other locations."

Answered by AI

What is the total number of people participating in this clinical trial?

"Yes, the information on clinicaltrials.gov indicates that this trial is currently recruiting patients. The study was originally posted on 8/28/2020 and last updated on 11/7/2022. The study is looking for 100 patients across 8 sites."

Answered by AI
~26 spots leftby Mar 2025