BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Recruiting
Phase 1
Phase 2
Interventional Study
Colorectal Cancer
Pancreatic Cancer
Gastric Cancers
Cholangiocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 220 (estimated)
- Sponsor
- Bold Therapeutics, Inc. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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 hav…
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