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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Bold Therapeutics, Inc.
Study ID
NCT04421820
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BOLD-100 +/- FOLFOX Chemotherapy (Arm VII) — DRUG
    Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone
  • BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI) — DRUG
    BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy

Study Details

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.

Key Dates

Start date
Aug 28, 2020
Status verified
May 2026
Primary completion
Jun 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)
    Arm closed to enrollment.
  • Experimental: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)
    Arm closed to enrollment.
  • Experimental: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)
    Arm closed to enrollment.
  • Experimental: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)
    Arm closed to enrollment.
  • Experimental: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)
    Arm closed to enrollment.
  • Experimental: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)
    Arm closed to enrollment.
  • Active Comparator: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIA)
    Arm open to enrollment. 500 mg/m2 BOLD-100 + SOC FOLFOX
  • Active Comparator: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIB)
    Arm open to enrollment. 625 mg/m2 BOLD-100 + FOLFOX
  • Active Comparator: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VIIC)
    Arm open to enrollment. FOLFOX alone.

Primary Outcome Measure

Incidence and severity of adverse events ([S]AEs) [ Time Frame: Through study completion, approximately 2 weeks after last treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesSanta MonicaCalifornia90095-
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Santa Monica, CA

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
University of California, Los Angeles· Santa Monica, CAMoffitt Cancer Center· Tampa, FL

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