A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
3 other identifiers
interventional
216
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2023
Longer than P75 for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
March 28, 2023
CompletedStudy Start
First participant enrolled
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
February 9, 2026
February 1, 2026
3.5 years
March 17, 2023
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDE
* Incidence of Dose Limiting Toxicities * Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Approximately 2 years
Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE
* Incidence of treatment-emergent AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
Approximately 4 years
Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab
Tumor response: Overall Response Rate assessed using RECIST criteria v1.1
Approximately 4 years
Secondary Outcomes (7)
Part 2 (Dose Expansion) Assess the risk/benefit at an IDE161 monotherapy dose and exposure alternative to the initial expansion dose; as well as an IDE161 dose in combination with a fixed dose of pembrolizumab and exposure alternative to the initial
Approximately 4 years
To characterize the single dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Approximately 4 years
To characterize the multiple dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Approximately 4 years
To characterize the single dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.
Approximately 4 years
To characterize the multiple dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.
Approximately 4 years
- +2 more secondary outcomes
Study Arms (4)
Module 1 Part 1: Monotherapy Dose Escalation
EXPERIMENTALParticipants will be assigned to a dose level.
Module 1 Part 2: Monotherapy Dose Expansion
EXPERIMENTALAfter a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
Module 2 Part 1: Combination Dose Escalation with pembrolizumab
EXPERIMENTALParticipants will be assigned to a dose level.
Module 2 Part 2: Combination Dose Expansion with pembrolizumab
EXPERIMENTALAfter a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
Interventions
Oral Medication
Intravenous Infusion
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- Have current active liver or biliary disease
- For Module 2 only, History or allogeneic tissue/solid organ transplant
- For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years
- For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDEAYA Bioscienceslead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (27)
HonorHealth Research Institute
Phoenix, Arizona, 85027, United States
The Angeles Clinic
Los Angeles, California, 90025, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Sarah Cannon Research Institute
Denver, Colorado, 80218, United States
Yale University
New Haven, Connecticut, 06511, United States
Orlando Health
Orlando, Florida, 32806, United States
Emory University
Atlanta, Georgia, 30322, United States
OSF St Francis Medical Center
Peoria, Illinois, 61637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Dana Faber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weil Cornell University
New York, New York, 10065, United States
Sarah Cannon Research Institute - Oklahoma University
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute - Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MD Anderson
Houston, Texas, 77030, United States
NEXT Oncology
Irving, Texas, 75039, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
START Mountain Region
West Valley City, Utah, 84119, United States
NEXT Oncology
Fairfax, Virginia, 22031, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Darrin Beaupre, MD,PhD
IDEAYA Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2023
First Posted
March 28, 2023
Study Start
April 18, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
February 9, 2026
Record last verified: 2026-02