A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Solid Tumor
Unknown Primary
Uterine Cancer
18 Years and older, Male and Female
IDE161-001 (primary)
NCI-2023-03139
Summary
The purpose of this study is to characterize the safety, tolerability, and efficacy of
IDE161 as a single agent and in combination with pembrolizumab.
Objectives
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
and in combination with pembrolizumab in participants with advanced/recurrent endometrial
cancer.
Eligibility
- Adult participants must be 18 years of age or older
- Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
- 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.
- 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
- For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
- For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)
Treatment Sites in Georgia
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