Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Bold Therapeutics.
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 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (86% lower). The trial reports 16 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
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 |
What NCT04421820 shows while recruiting
NCT04421820 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (86% lower).
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 lists 16 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04421820's enrollment target sits among peer trials
220 139th of 381 higher than 241 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00920972 · 220 participants · Phase 1
Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
- NCT01851642 · 220 participants
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
- NCT02582021 · 220 participants
WISE CVD - Continuation (WISE HFpEF)
- NCT04067830 · 220 participants · Phase 2
Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI