Advanced or Metastatic Solid TumorsPhase 1NCT05787587

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

A Phase 1 study testing IDE-161 and Pembrolizumab in people with Advanced or Metastatic Solid Tumors and Breast Cancer, run by IDEAYA Biosciences at 27 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer
What is being tested?: IDE-161 and Pembrolizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 27 sitesUnited States
Study dates: 18 Apr 2023to May 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

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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

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Emory University
Atlanta, Georgia, 30322
Dana Faber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Sarah Cannon Research Institute
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
NEXT Oncology
Fairfax, Virginia, 22031
MD Anderson
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
NEXT Oncology
Irving, Texas, 75039
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
The Angeles Clinic
Los Angeles, California, 90025
University of Wisconsin
Madison, Wisconsin, 53792
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06511
Columbia University Medical Center
New York, New York, 10032
Weil Cornell University
New York, New York, 10065
Hoag Memorial Hospital
Newport Beach, California, 92663
Sarah Cannon Research Institute - Oklahoma University
Oklahoma City, Oklahoma, 73104
Orlando Health
Orlando, Florida, 32806
OSF St Francis Medical Center
Peoria, Illinois, 61637
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sarah Cannon Research Institute - Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
HonorHealth Research Institute
Phoenix, Arizona, 85027
NEXT Oncology
San Antonio, Texas, 78229
California Pacific Medical Center
San Francisco, California, 94115
Swedish Cancer Institute
Seattle, Washington, 98104
START Mountain Region
West Valley City, Utah, 84119

Other trials in United States

About this study

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

Read the 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
Being tested: IDE-161, Pembrolizumab
Keywords: PARPi, PARP inhibitor, BRCA, HRD gene alteration, Breast, Ovarian, Advanced solid tumors, Metastatic solid tumors, BRCA 1, BRCA 2, Homologous recombination, PARG, PARG Inhibition, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL
Medical subject headings: Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Mental Retardation, X-Linked, With Or Without Seizures, Arx-Related

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IDE-161Drug
Oral Medication
PembrolizumabDrug
Also called KEYTRUDA®
Intravenous Infusion

Study groups in NCT05787587
Study group	Role	What they receive
Module 1 Part 1: Monotherapy Dose Escalation	Experimental	Participants will be assigned to a dose level. Receives: Drug: IDE-161
Module 1 Part 2: Monotherapy Dose Expansion	Experimental	After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level. Receives: Drug: IDE-161
Module 2 Part 1: Combination Dose Escalation with pembrolizumab	Experimental	Participants will be assigned to a dose level. Receives: Drug: IDE-161; Drug: Pembrolizumab
Module 2 Part 2: Combination Dose Expansion with pembrolizumab	Experimental	After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level. Receives: Drug: IDE-161; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Descriptively compare the totality of emerging data (efficacy, safety, PK, PD) between the initial expansion dose cohort and dose optimization cohort
Measured: Approximately 4 years
To characterize the single dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Single-dose PK parameters of IDE161
Measured: Approximately 4 years
To characterize the multiple dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Multiple-dose PK parameters of IDE161
Measured: 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.
Single-dose PK parameters of IDE161
Measured: 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.
Multiple-dose PK parameters of IDE161
Measured: Approximately 4 years
To characterize the single dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.
Single-dose PK parameters of IDE161
Measured: Approximately 4 years
To characterize the multiple dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.
Multiple-dose PK parameters of IDE161
Measured: Approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 2023May 2027

First posted28 Mar 2023
Study start18 Apr 2023
Primary completionOct 2026 (estimated)
Study completionMay 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Sequential
Masking: None (open label)
Enrolment: 216 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05787587
Sponsor's protocol ID: IDE161-001
Other IDs: KEYNOTE-F86, MK-3475-F86
Status last verified: Jul 2026
First submitted: 17 Mar 2023
Last updated: 13 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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