AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBold Therapeutics, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Be 18 years or older. 2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol. 3. Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable. (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting. 4. Have measurable disease according to RECIST v1.1. 5. Have an anticipated survival of at least 16 weeks. 6. Be ambulatory, with an ECOG performance score of 0 or 1. 7. Have adequate organ function. 8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion. 9. Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF). 10. (ARM VII): BRAF wild-type tumour status. Exclusion Criteria: 1. Neuropathy \> grade 2 2. Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin. 3. Cerebrovascular accident within the past 6 months before the start of treatment. 4. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours. 5. Any serious medical conditions that might be aggravated by treatment or limit compliance. 6. Any history of serious cardiac illness. 7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment. 8. Any other known malignancy within 3 years before the start of treatment. 9. Active gastrointestinal tract disease with malabsorption syndrome. 10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. 11. Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment. 12. Recent history of weight loss \> 10% of current body weight in past 3 months before the start of treatment. 13. HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent. 14. Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment. 15. Currently breastfeeding 16. Dihydropyrimidine Dehydrogenase (DPD) deficiency 17. Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD) 18. (ARM VII): Prior exposure to BOLD-100 19. (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours 20. (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
๐Ÿ’Š

What it tests

  • BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
  • BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
๐Ÿ“

Where

24 sites
University of California, Los Angeles
Santa Monica, United States
Moffitt Cancer Center
Tampa, United States
Cross Cancer Institue
Edmonton, Canada
Juravinski Cancer Centre
Hamilton, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Jewish General Hospital
Montreal, Canada
McGill University Health Centre Glen Site
Montreal, Canada

โ€ฆand 16 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy