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Testing IDE161 for advanced solid tumors

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

Phase 1 Interventional IDEAYA Biosciences · NCT05787587

This study is testing a new drug called IDE161, alone and with another medication, to see if it can help people with advanced solid tumors that have specific genetic changes.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment216 (estimated)
Ages18 Years and up
SexAll
SponsorIDEAYA Biosciences Industry-sponsored
Drugs / interventionschemotherapy, Radiation, pembrolizumab
Locations27 sites (Phoenix, Arizona and 26 other locations)
Trial IDNCT05787587 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and effectiveness of IDE161, a PARG inhibitor, both alone and in combination with pembrolizumab for patients with advanced or metastatic solid tumors. It aims to determine the maximum tolerated dose and recommended doses for further testing, while also assessing pharmacokinetics and preliminary anti-tumor activity. Participants must have specific genetic alterations related to homologous recombination deficiency, particularly BRCA1/2 mutations, or have advanced endometrial cancer that has progressed on prior treatments.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors harboring BRCA1/2 mutations or other homologous recombination deficiencies who have progressed on prior therapies.

Not a fit: Patients with primary central nervous system tumors or those who have not progressed on prior lines of therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have specific genetic vulnerabilities.

How similar studies have performed: Other studies involving PARG inhibitors and similar genetic targeting approaches have shown promise, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced or Metastatic Solid TumorsBreast CancerOvarian CancerProstate CancerEndometrial CancerColorectal CancerHead and Neck CancersExtensive Stage Small Cell Lung Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.