- Recruiting
- Treatment
- Interventional
- Non Randomized
- Drug
- PHASE1
- IDEAYA Biosciences
- 18 Years -
Study Purpose
The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.
Intervention
Drug : IDE-161
Drug : Pembrolizumab
Eligibility Requirements
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)
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
Recruiting status
Recruiting
Estimated enrollment
216
Study start date
Apr 05, 2023
Study end date
May 31, 2027
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug
Study phase
PHASE1
Allocation
Non Randomized
Sponsor:
IDEAYA Biosciences
Collaborator:
Merck Sharp & Dohme LLC
Investigator:
Darrin Beaupre, MD,PhD
Publications
N/A
Websites
N/A
NCT05787587
Clinic | Location | Investigator | Distance | RECRUITING STATUS | Contact |
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