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

NCT04421820 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-05-18

No results posted yet for this 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

Interventions

DRUG

BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)

Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone

DRUG

BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy

Sponsors & Collaborators

  • Bold Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2026-06-01
Completion
2026-09-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Ireland
  • Italy
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421820 on ClinicalTrials.gov