A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer
About this trial
This is an interventional treatment trial for Advanced or Metastatic Solid Tumors focused on measuring PARPi, PARP inhibitor, BRCA, HRD gene alteration, Breast, Ovarian, Advanced solid tumors, Metastatic solid tumors, BRCA 1, BRCA 2, Homologous recombination, PARG, PARG Inhibition, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51C, RAD51D, RAD54L, NBN, FANCA, HRD+
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
Sites / Locations
- Sarah Cannon Research InstituteRecruiting
- Sarah Cannon Research Institute
- Sarah Cannon Research Institute
- Sarah Cannon Research InstituteRecruiting
- MD AndersonRecruiting
- NEXT OncologyRecruiting
- NEXT OncologyRecruiting
- START Mountain RegionRecruiting
- NEXT OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Module 1 Part 1: Monotherapy Dose Escalation
Module 1 Part 2: Monotherapy Dose Expansion
Participants will be assigned to a dose level.
After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.