NCT05787587

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: IDEAYA Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Advanced or Metastatic Solid Tumors
• Breast Cancer
• Ovarian Cancer
• Prostate Cancer
• Endometrial Cancer
• Colorectal Cancer
• Head and Neck Cancers
• Extensive Stage Small Cell Lung Cancer (ES-SCLC)
• NSCLC

Interventions

Type	Name	Description
DRUG	IDE-161	Oral Medication
DRUG	Pembrolizumab	Intravenous Infusion

Timeline

• Start date: 2023-04-18
• Primary completion: 2026-10-01
• Completion: 2027-05-01
• First posted: 2023-03-28
• Last updated: 2026-02-09

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study