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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IDEAYA Biosciences

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Known primary CNS malignancy

2. Impairment of GI function or GI disease that may significantly alter the absorption of IDE161

3. Have active, uncontrolled infection

4. Clinically significant cardiac abnormalities

5. Major surgery within 4 weeks prior to enrollment

6. Radiation therapy within 2 weeks prior to enrollment

7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment

8. Radioimmunotherapy within 6 weeks of enrollment

9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment

10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter