A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
IDE161-001 (primary)
NCI-2023-03139
Summary
The purpose of this study is to characterize the safety, tolerability, and efficacy of
IDE161.
Objectives
The purpose of this study is to characterize the safety, tolerability including
determination of maximum tolerated dose (MTD), maximum accepted dose (MAD), recommended
dose(s) for expansion (RDE) and/or recommended Phase 2 dose (RP2D), pharmacokinetics
(PK), pharmacodynamics (PD) and preliminary anti-tumor activity of IDE161 as a single
agent in participants with advanced or metastatic solid tumors harboring BRCA1/2 loss of
function alterations and/or other defects in the homologous recombination (HR) pathway.
Eligibility
- Adult participants must be 18 years of age or older
- Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
- Have documented evidence of genetic alterations conferring homologous recombination deficiency
- Participant must have progressed on at least one prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care, or for which the participant has documented intolerance
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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