A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Drug
  • PHASE1
  • IDEAYA Biosciences
  • 18 Years -


Study Purpose

The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.

Intervention

Drug : IDE-161

Drug : Pembrolizumab


Eligibility Requirements

info icon Adult participants must be 18 years of age or older

info icon Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors

info icon 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)

info icon For Module 2 only, results of MSI and/or MMR testing required.

info icon For Module 2 only, results of BRCA1/2 and HRD gene testing required.

info icon 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

info icon For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)

info icon For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)

info icon Known primary CNS malignancy

info icon Impairment of GI function or GI disease that may significantly alter the absorption of IDE161

info icon Have active, uncontrolled infection

info icon Clinically significant cardiac abnormalities

info icon Major surgery within 4 weeks prior to enrollment

info icon Radiation therapy within 2 weeks prior to enrollment

info icon Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment

info icon Radioimmunotherapy within 6 weeks of enrollment

info icon Treatment with a therapeutic antibody within 4 weeks prior to enrollment

info icon Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter

info icon Have current active liver or biliary disease

info icon For Module 2 only, History or allogeneic tissue/solid organ transplant

info icon For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years

info icon For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Recruiting status

Recruiting

Estimated enrollment

216

 
Study start date

Apr 05, 2023

Study end date

May 31, 2027

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1

Allocation

Non Randomized

 

Sponsor:

IDEAYA Biosciences

Collaborator:

Merck Sharp & Dohme LLC

Investigator:

Darrin Beaupre, MD,PhD

NCT05787587

Clinic Location Investigator Distance RECRUITING STATUS Contact