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

Recruiting now · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Pancreatic Cancer, Gastric Cancers, Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT04421820

Run by

Bold Therapeutics, Inc.

People needed

220

Starts

2020-08-28

Expected to finish

2026-09-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be 18 years or older.
• Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
• 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.
• Have measurable disease according to RECIST v1.1.
• Have an anticipated survival of at least 16 weeks.
• Be ambulatory, with an ECOG performance score of 0 or 1.
• Have adequate organ function.
• Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion.
• Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF).
• (ARM VII): BRAF wild-type tumour status.

You may not qualify if…

• Neuropathy > grade 2
• Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin.
• Cerebrovascular accident within the past 6 months before the start of treatment.
• History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
• Any serious medical conditions that might be aggravated by treatment or limit compliance.
• Any history of serious cardiac illness.
• Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment.
• Any other known malignancy within 3 years before the start of treatment.
• Active gastrointestinal tract disease with malabsorption syndrome.
• Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
• Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment.
• Recent history of weight loss > 10% of current body weight in past 3 months before the start of treatment.
• HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
• Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
• Currently breastfeeding
• Dihydropyrimidine Dehydrogenase (DPD) deficiency
• Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
• (ARM VII): Prior exposure to BOLD-100
• (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours
• (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)

Where it is running

• National Cancer Center — Goyang, South Korea (enrolling)
• Kangbuk Samsung Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital - Yonsei University — Seoul, South Korea (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• McGill University Health Centre Glen Site — Montreal, Quebec, Canada (enrolling)
• Universitatsklinikum Bonn — Bonn, Germany (enrolling)
• University Hospital of Ulm — Ulm, Germany (enrolling)
• Mater Miserecordiae University Hospital — Dublin, Ireland (enrolling)
• St. James Hospital — Dublin, Ireland (enrolling)
• St. Vincent's University Hospital — Dublin, Ireland (enrolling)
• Cross Cancer Institue — Edmonton, Alberta, Canada (enrolling)
• Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
• The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (enrolling)
• Hospital 12 de Octubre — Madrid, Spain
• Moffitt Cancer Center — Tampa, Florida, United States
• Fondazione IRCCS "Istituto Nazionale dei Tumori — Milan, Italy
• AOU L. Vanvitelli — Naples, Italy
• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
• Vall Hebron Institute of Oncology (VHIO) — Barcelona, Spain
• Early Phase Unit FJD START Madrid — Madrid, Spain
• University of California, Los Angeles — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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