A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
- Study HIC#:2000036221
- Last Updated:09/06/2024
The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161.
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
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 Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known primary CNS malignancy
- Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
- Have active, uncontrolled infection
- Clinically significant cardiac abnormalities
- Major surgery within 4 weeks prior to enrollment
- Radiation therapy within 2 weeks prior to enrollment
- Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
- Radioimmunotherapy within 6 weeks of enrollment
- Treatment with a therapeutic antibody within 4 weeks prior to enrollment
- Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter