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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Arizona
HonorHealth Research Institute
RECRUITING
Phoenix
California
The Angeles Clinic
RECRUITING
Los Angeles
Hoag Memorial Hospital
RECRUITING
Newport Beach
California Pacific Medical Center
WITHDRAWN
San Francisco
Colorado
Sarah Cannon Research Institute
RECRUITING
Denver
Connecticut
Yale University
RECRUITING
New Haven
Florida
Orlando Health
WITHDRAWN
Orlando
Georgia
Emory University
RECRUITING
Atlanta
Illinois
OSF St Francis Medical Center
RECRUITING
Peoria
Indiana
Indiana University
COMPLETED
Indianapolis
Massachusetts
Dana Faber Cancer Institute
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
New York
Roswell Park Comprehensive Cancer Center
COMPLETED
Buffalo
Columbia University Medical Center
COMPLETED
New York
Weil Cornell University
RECRUITING
New York
Oklahoma
Sarah Cannon Research Institute - Oklahoma University
RECRUITING
Oklahoma City
Pennsylvania
Sarah Cannon Research Institute - Thomas Jefferson University
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
MD Anderson
RECRUITING
Houston
NEXT Oncology
RECRUITING
Irving
NEXT Oncology
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Oncology
RECRUITING
Fairfax
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
IDEAYA Clinical Trials
IDEAYAClinicalTrials@ideayabio.com
855-IDEA-BIO (855-433-2246)
Time Frame
Start Date: 2023-04-05
Estimated Completion Date: 2027-05
Participants
Target number of participants: 216
Treatments
Experimental: Module 1 Part 1: Monotherapy Dose Escalation
Participants will be assigned to a dose level.
Experimental: Module 1 Part 2: Monotherapy Dose Expansion
After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
Experimental: Module 2 Part 1: Combination Dose Escalation with pembrolizumab
Participants will be assigned to a dose level.
Experimental: Module 2 Part 2: Combination Dose Expansion with pembrolizumab
After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: IDEAYA Biosciences

This content was sourced from clinicaltrials.gov