Actively Recruiting
A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.
Led by FoRx Therapeutics AG · Updated on 2026-01-21
40
Participants Needed
8
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Histologically or cytologically confirmed advanced or metastatic selected solid tumors
- Progression after at least 1 prior line of standard therapy in advanced or metastatic setting
- Documented genetic alterations including BRCA1/2 mutations or other homologous recombination deficiencies or high replication stress
- For dose expansion: specific tumor types with documented genomic abnormalities including breast and ovarian cancers
- Measurable disease per RECIST 1.1 criteria
- Adequate bone marrow and organ function based on laboratory tests within 14 days before first dose
- ECOG performance status 0 to 2 with at least 3 months life expectancy (Dose Escalation); ECOG 0 to 1 for backfilling and Dose Expansion
- Ability to swallow tablets with no gastrointestinal absorption issues
You will not qualify if you...
- Anti-cancer treatment or investigational agent received within 14 days or 5 half-lives, or immunotherapy within 28 days before first dose
- Previous exposure to a PARG inhibitor
- History of other malignancies within 5 years except certain treated localized cancers
- Major surgery within 30 days prior to first dose or planned major surgery during study
- Impaired cardiovascular function or significant cardiovascular disease
- Uncontrolled HIV or hepatitis C infection
- Known metastatic central nervous system or leptomeningeal disease, except stable brain metastases under specified conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Stanford University Medical Center
Palo Alto, California, United States, 94304
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
START - Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
4
Washington University St. Louis
St Louis, Missouri, United States, 63108
Actively Recruiting
5
Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
6
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
START - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
8
NEXT - Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
J
Jens Wuerthner, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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