New cancer drug IDE161 enters human testing

NCT ID NCT05787587

Disease control Sponsor: IDEAYA Biosciences Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 14, 2026 · Updated 4 times

Summary

This early-stage trial is testing a new drug called IDE161, alone or with the immunotherapy pembrolizumab, in adults with advanced solid tumors (like breast, ovarian, prostate, or lung cancer). The main goals are to check safety, find the right dose, and get a first look at whether it shrinks tumors. About 216 people will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: IDE-161 (PARG inhibitor) and pembrolizumab (immunotherapy)
What this could lead to: If successful, this could point toward a new treatment option for certain advanced cancers, especially those with DNA repair deficiencies.
What could go wrong: This is an early Phase 1 trial, so safety and dosing are still being figured out. Many drugs fail at this stage, and benefits may be limited or not seen at all.

Why investors are watching

Ideaya Biosciences is testing its drug IDE161, a PARG inhibitor, in 216 people with advanced solid tumors, both alone and with the immunotherapy pembrolizumab. This early-stage trial is the first major test of IDE161 in humans, and for a small company, the safety and early signs of tumor control will shape whether the drug has a future.

If it works: If IDE161 shows acceptable safety and signs of disease control, Ideaya could advance the drug to later trials and build a new pipeline asset. A positive result may also strengthen the company's position with partners or investors.

If it fails: Phase 1 trials often fail because the drug proves unsafe or shows little benefit, and a poor result could force Ideaya to abandon IDE161. Delays in enrollment or data readouts could also hurt the company's momentum.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult participants must be 18 years of age or older 2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors 3. 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. 4. 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 5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded) 6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB) Exclusion Criteria: 1. Known primary CNS malignancy 2. Impairment of GI function or GI disease that may significantly alter the absorption of IDE161 3. Have active, uncontrolled infection 4. Clinically significant cardiac abnormalities 5. Major surgery within 4 weeks prior to enrollment 6. Radiation therapy within 2 weeks prior to enrollment 7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment 8. Radioimmunotherapy within 6 weeks of enrollment 9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment 10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter 11. Have current active liver or biliary disease 12. For Module 2 only, History or allogeneic tissue/solid organ transplant 13. For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years 14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm head and neck cancer Head and Neck Neoplasms intellectual disability, X-linked, with or without seizures, ARX-related metastatic malignant neoplasm neoplasm non-small cell lung carcinoma ovarian cancer prostate cancer small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic solid tumors Breast cancer Colorectal cancer Endometrial cancer Extensive-stage small cell lung cancer (es-SCLC) Head and neck cancers NSCLC Ovarian cancer Prostate cancer

Contacts and locations

Locations

California Pacific Medical Center

San Francisco, California, 94115, United States
Columbia University Medical Center

New York, New York, 10032, United States
Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States
Dana Faber Cancer Institute

Boston, Massachusetts, 02215, United States
Emory University

Atlanta, Georgia, 30322, United States
Hoag Memorial Hospital

Newport Beach, California, 92663, United States
HonorHealth Research Institute

Phoenix, Arizona, 85027, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
MD Anderson

Houston, Texas, 77030, United States
NEXT Oncology

Irving, Texas, 75039, United States
NEXT Oncology

San Antonio, Texas, 78229, United States
NEXT Oncology

Fairfax, Virginia, 22031, United States
OSF St Francis Medical Center

Peoria, Illinois, 61637, United States
Orlando Health

Orlando, Florida, 32806, United States
Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States
START Mountain Region

West Valley City, Utah, 84119, United States
Sarah Cannon Research Institute

Denver, Colorado, 80218, United States
Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute - Oklahoma University

Oklahoma City, Oklahoma, 73104, United States
Sarah Cannon Research Institute - Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
Swedish Cancer Institute

Seattle, Washington, 98104, United States
The Angeles Clinic

Los Angeles, California, 90025, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Wisconsin

Madison, Wisconsin, 53792, United States
Weil Cornell University

New York, New York, 10065, United States
Yale University

New Haven, Connecticut, 06511, United States

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