RecruitingPhase 1Phase 2NCT04421820

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


Sponsor

Bold Therapeutics, Inc.

Enrollment

220 participants

Start Date

Aug 28, 2020

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BOLD-100 in combination with a standard chemotherapy regimen called FOLFOX for patients with advanced gastrointestinal cancers (such as colorectal, stomach, or pancreatic cancer) that have spread or cannot be removed with surgery. **You may be eligible if...** - You are 18 or older - You have a gastrointestinal cancer that has spread or cannot be surgically removed, confirmed by biopsy - You have measurable disease on scans - You are in good health (ECOG 0–1) and have adequate organ function - For one specific treatment arm: you have received only 1 prior treatment and your tumor does not have a BRAF mutation **You may NOT be eligible if...** - You have nerve damage worse than grade 2 - You previously could not tolerate fluorouracil (5-FU) or oxaliplatin (components of FOLFOX) - You have cancer in the brain or spinal fluid - You had a stroke in the past 6 months - You have serious heart disease or recent internal bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(16)

University of California, Los Angeles

Santa Monica, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Cross Cancer Institue

Edmonton, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre Glen Site

Montreal, Quebec, Canada

Mater Miserecordiae University Hospital

Dublin, Ireland

St. James Hospital

Dublin, Ireland

St. Vincent's University Hospital

Dublin, Ireland

National Cancer Center

Goyang, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital - Yonsei University

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT04421820