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

Study Identifier:
IDE161-001
CT.gov Identifier:
NCT05787587
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate IDE161, a small molecule inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of patients having solid tumors with homologous recombination deficiency (HRD).

To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 as monotherapy in BRCA1/2-mutant breast and ovarian cancer patients.

To evaluate IDE161/pembrolizumab combination therapy In patients with advanced endometrial cancer who have previously progressed on anti-PD-1 therapy

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Breast Cancers
  • Ovarian
  • Prostate
  • Endometrial
  • Bowel (Colorectal)
  • Head & Neck
  • Small Cell Lung
  • Non-Small Cell Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Patients will receive IDE161 as monotherapy.
    • Read More
  • Drug: Experimental: Module 1 Part 1: Monotherapy Dose Escalation
  • Drug: Experimental: Module 1 Part 2: Monotherapy Dose Expansion
  • Drug: Experimental: Module 2 Part 1: Combination Dose Escalation with pembrolizumab
  • Drug: Drug: Pembrolizumab
  • Drug: Experimental: Module 2 Part 2: Combination Dose Expansion with pembrolizumab
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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)
    Exclusion criteria
    • 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Breast Cancers
    Ovarian
    Prostate
    Endometrial
    Bowel (Colorectal)
    Head & Neck
    Small Cell Lung
    Non-Small Cell Lung Cancer