A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.

Part of paid clinical trials in Palo Alto, California.

Sponsor
FoRx Therapeutics AG
Study ID
NCT07356453
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • FORX-428 — DRUG
    FORX-428 drug product is formulated as immediate release tablets for oral administration in 3 dosage strengths containing 10 mg, 50 mg, and 100 mg FORX-428 drug substance.

Study Details

The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-48 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or high replication stress, and to determine the maximum tolerated dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 as monotherapy.

Key Dates

Start date
Jul 22, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: First-in-human single-arm, open-label, multicenter Phase 1 dose escalation/expansion cohort study.
    FORX 428 dose levels planned in the study: Dose Level 1: 30 mg, daily; Dose Level 2: 60 mg, daily; Dose Level 3: 120 mg, daily; Dose Level 4: 200 mg, daily; Dose Level 5: 300 mg, daily; and Dose Level 6: 400 mg, daily. Following the selection of the Recommended Cohort Expansion Dose during Part 1 of the study, new patients will be included in 3 cohorts, with simultaneous parallel enrollment. Patients will be allowed to continue to receive FORX-428 monotherapy until disease progression or unacceptable toxicity. Part 2 will include approximately up to 29 evaluable patients in each expansion cohort as determined by the Simon's optimal 2-stage design. In Stage 1 of each cohort of Part 2, a total number of 10 patients will be accrued. If there are 1 or fewer responses by RECIST version 1.1 among these 10 patients, further enrollment in that cohort will be halted for futility. Otherwise, an additional 19 patients will be accrued per cohort in Stage 2 of Part 2.

Primary Outcome Measure

Dose Escalation Phase: Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: 1 year. ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterPalo AltoCalifornia94304
Study Coordinator
650-723-4000
University of California, San FranciscoSan FranciscoCalifornia94143
Study Coordinator
888-689-8273
START - MidwestGrand RapidsMichigan49546
Study Coordinator
616-954-5554
Washington University St. LouisSt LouisMissouri63108
Study Coordinator
800-600-3606
Knight Cancer InstitutePortlandOregon97239
Study Coordinator
503-494-8311
University of Texas - MD Anderson Cancer CenterHoustonTexas77030
Study Coordinator
866-541-1846
START - San AntonioSan AntonioTexas78229
Study Coordinator
210-593-5250
NEXT - Virginia Cancer SpecialistsFairfaxVirginia22031
Study Coordinator
703-783-4510

Find similar trials in Palo Alto, CA

By research site
Stanford University Medical Center· Palo Alto, CAUniversity of California, San Francisco· San Francisco, CASTART - Midwest· Grand Rapids, MIWashington University St. Louis· St Louis, MOKnight Cancer Institute· Portland, ORUniversity of Texas - MD Anderson Cancer Center· Houston, TX

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