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NCT04421820 · ClinicalTrials.gov registry record · Phase 1
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
A Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Bold Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
- 16
- Study locations
NCT04421820 is a Phase 1 study of Colorectal Cancer and Pancreatic Cancer that is actively recruiting participants, run by Bold Therapeutics. The registered enrollment target is 220 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (85% lower). The trial reports 16 study locations across 6 states.
The verdict
NCT04421820, a Phase 1 study of Colorectal Cancer and Pancreatic Cancer, is actively recruiting participants, sponsored by Bold Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
- 16
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
- DRUG BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
Study Locations (16)
Other
- Mater Miserecordiae University Hospital - Dublin
- St. James Hospital - Dublin
- St. Vincent's University Hospital - Dublin
- National Cancer Center - Goyang
- Kangbuk Samsung Hospital - Seoul
- Samsung Medical Center - Seoul
- Seoul National University Hospital - Seoul
- Severance Hospital - Yonsei University - Seoul
Ontario
- Juravinski Cancer Centre - Hamilton
- The Ottawa Hospital Cancer Centre - Ottawa
- Princess Margaret Cancer Centre - Toronto
Quebec
- Jewish General Hospital - Montreal
- McGill University Health Centre Glen Site - Montreal
California
- University of California, Los Angeles - Santa Monica
Florida
- Moffitt Cancer Center - Tampa
Alberta
- Cross Cancer Institue - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04421820
The ClinicalTrials.gov registry entry for NCT04421820 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (85% lower). The listed sponsor is Bold Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which BOLD-100 +/- FOLFOX Chemotherapy (Arm VII) is the first listed.
NCT04421820 reports 16 study locations spanning 6 distinct geographic areas - top geographies include Other, Ontario, Quebec.
Frequently Asked Questions
What is clinical trial NCT04421820 about?
NCT04421820 is a clinical study titled "BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours". 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 ch...
What is the current status of trial NCT04421820?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2020-08-28. Estimated completion is 2026-09-01.
What conditions does trial NCT04421820 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Cancer, Cholangiocarcinoma, Gastric Cancers.
What interventions are being tested in trial NCT04421820?
The interventions under investigation include: BOLD-100 +/- FOLFOX Chemotherapy (Arm VII) (DRUG), BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) (DRUG).
Who is sponsoring clinical trial NCT04421820?
This trial is sponsored by Bold Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04421820 being conducted?
This trial has 16 study locations across California, Florida, Alberta, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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