Actively Recruiting
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Led by Bold Therapeutics, Inc. · Updated on 2026-05-04
220
Participants Needed
18
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older
- Be male or non-pregnant female and agree to follow contraceptive requirements
- Have histologically or cytologically confirmed metastatic or unresectable gastrointestinal tumors
- For Arm VII, have received only 1 prior metastatic therapy line
- Have measurable disease by RECIST v1.1
- Have expected survival of at least 16 weeks
- Be ambulatory with ECOG performance score of 0 or 1
- Have adequate organ function
- Be on stable doses of medications affecting liver or kidney drug processing
- Be fully informed about the illness and study and sign consent
- For Arm VII, have BRAF wild-type tumor status
You will not qualify if you...
- Neuropathy greater than grade 2
- Previous intolerance or severe reaction to fluorouracil or oxaliplatin
- Stroke within 6 months before starting treatment
- History or presence of central nervous system metastases or leptomeningeal tumors
- Serious medical conditions that could worsen with treatment or limit compliance
- History of serious heart disease
- Bleeding in lungs, brain, or significant gastrointestinal bleeding within 6 months before treatment
- Any other cancer within 3 years before starting treatment
- Active gastrointestinal disease with malabsorption
- Non-healing wounds, fractures, ulcers, or symptomatic peripheral vascular disease
- Radiation therapy or surgery within 4 weeks before treatment start
- Weight loss over 10% in past 3 months before treatment
- HIV infection on combination anti-retroviral therapy
- Use of other investigational or anti-cancer therapy within 4 weeks before treatment
- Currently breastfeeding
- Dihydropyrimidine Dehydrogenase (DPD) deficiency
- Current or prior use of strong DPD inhibitors
- For Arm VII, prior exposure to BOLD-100
- For Arm VII, tumors with microsatellite instability-high (MSI-H)
- For Arm VII, concurrent monoclonal antibody therapy for metastatic colorectal cancer (anti-EGFR, anti-VEGF, or anti-HER2)
AI-Screening
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Trial Site Locations
Total: 18 locations
1
University of California, Los Angeles
Santa Monica, California, United States, 90095
Completed
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Completed
3
Cross Cancer Institue
Edmonton, Alberta, Canada
Actively Recruiting
4
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Actively Recruiting
5
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Actively Recruiting
6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Actively Recruiting
7
Jewish General Hospital
Montreal, Quebec, Canada
Actively Recruiting
8
McGill University Health Centre Glen Site
Montreal, Quebec, Canada
Actively Recruiting
9
Universitatsklinikum Bonn
Bonn, Germany
Actively Recruiting
10
University Hospital of Ulm
Ulm, Germany
Actively Recruiting
11
Mater Miserecordiae University Hospital
Dublin, Ireland
Actively Recruiting
12
St. James Hospital
Dublin, Ireland
Actively Recruiting
13
St. Vincent's University Hospital
Dublin, Ireland
Actively Recruiting
14
National Cancer Center
Goyang, South Korea
Actively Recruiting
15
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
16
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
17
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
18
Severance Hospital - Yonsei University
Seoul, South Korea
Actively Recruiting
Research Team
M
Michelle Jones
CONTACT
J
Jim Pankovich
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
9
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