Yükleniyor... / Loading...
This study evaluates IDE-161, a PARG inhibitor drug, alone or combined with Pembrolizumab, in adults with advanced or metastatic solid tumors. It includes tumors with alterations in genes such as BRCA1/2, and certain endometrial (uterine) cancer patients. The study is in Phase 1 and is currently active but not recruiting new participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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. For 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) For Module 2 only, results of MSI and/or MMR testing required. For Module 2 only, results of BRCA1/2 and HRD gene testing required. 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 5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded) 6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB) 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 11. Have current active liver or biliary disease 12. For Module 2 only, History or allogeneic tissue/solid organ transplant 13. For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years 14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease