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