RecruitingPhase 1NCT05787587
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Sponsor
IDEAYA Biosciences
Enrollment
216 participants
Start Date
Apr 18, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria14
- 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
Interventions
DRUGIDE-161
Oral Medication
DRUGPembrolizumab
Intravenous Infusion
Locations(27)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05787587
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