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A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05787587
Protocol IDs
IDE161-001 (primary)
NCI-2023-03139
Study Sponsor
IDEAYA Biosciences

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

  1. Adult participants must be 18 years of age or older
  2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
  3. Have documented evidence of genetic alterations conferring homologous recombination deficiency
  4. 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

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**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... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.