NCT07356453

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

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: FoRx Therapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 of FORX-428 as monotherapy; and * To evaluate the PK profile of FORX-428 when administered as monotherapy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	FORX-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.

Timeline

• Start date: 2025-07-22
• Primary completion: 2027-06-01
• Completion: 2028-04-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study