Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT04421820 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 220 participants
Start Date 2020-08-28
Est. Completion 2026-09-01
Phase Phase 1

Sponsor

Bold Therapeutics

1 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bold Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04421820 reports 16 study locations spanning 6 distinct geographic areas — top geographies include Other, Ontario, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04421820?

This trial is sponsored by Bold Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial