A Phase 1 Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors With BRCA1/2 Mutations or Other DDR Deficiencies or High Replication Stress.
FoRx Therapeutics AG
Summary
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.
Description
The primary objective of the Expansion cohorts (Part 2) of this study is to evaluate the preliminary anti-tumor activity of FORX-428 as monotherapy. Secondary Outcome Measures: The secondary objectives of Part 1 of this study are the following: * To evaluate the preliminary anti-tumor activity of FORX-428 as monotherapy; * To evaluate the PK profile of FORX-428 when administered as monotherapy; and * To evaluate a FORX-428-induced effect on heart rate-corrected QT interval (QTc). The secondary objectives of Part 2 of this study are the following: * To evaluate the safety and tolerability…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient must be \>/=18 years of age at time of signing informed consent; 2. Patient has histologically and/or cytologically confirmed diagnosis of advanced or metastatic selected solid tumors. 3. Patient must have progressed on at least 1 prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care. In general, if maintenance therapy is part of the standard of care, it should be considered as part of the "1 prior line of therapy in the advanced or metastatic setting" requirement; 4. Patient must fulfill genomic selection…
Interventions
- DrugFORX-428
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.
Locations (8)
- Stanford University Medical CenterPalo Alto, California
- University of California, San FranciscoSan Francisco, California
- START - MidwestGrand Rapids, Michigan
- Washington University St. LouisSt Louis, Missouri
- Knight Cancer InstitutePortland, Oregon
- University of Texas - MD Anderson Cancer CenterHouston, Texas