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Official Title
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Phase
Phase 1
Sponsor
IDEAYA Biosciences
Enrollment
216
Timeline
Apr 2023 → May 2027
About This Study
The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.
Eligibility Criteria
Inclusion Criteria
- 1Adult participants must be 18 years of age or older
- 2Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
- 3For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterations conferring homologous recombination deficiency (HRD) (ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L, NBN, FANCA)
- 4For Module 2 only, results of MSI and/or MMR testing required.
- 5For Module 2 only, results of BRCA1/2 and HRD gene testing required.
- 6Participant 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
- 7For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
- 8For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)
Exclusion Criteria
- 1Known primary CNS malignancy
- 2Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
- 3Have active, uncontrolled infection
- 4Clinically significant cardiac abnormalities
- 5Major surgery within 4 weeks prior to enrollment
- 6Radiation therapy within 2 weeks prior to enrollment
- 7Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
- 8Radioimmunotherapy within 6 weeks of enrollment
- 9Treatment with a therapeutic antibody within 4 weeks prior to enrollment
- 10Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter
- 11Have current active liver or biliary disease
- 12For Module 2 only, History or allogeneic tissue/solid organ transplant
- 13For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years
- 14For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Locations
27 sites participating in this study
Emory University
Atlanta, Georgia 30322
Kevin Kalinsky
HonorHealth Research Institute
Phoenix, Arizona 85027
Terry Thomas, MS, CCRC
The Angeles Clinic
Los Angeles, California 90025
Saba Mukarram
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →