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

Launched by IDEAYA BIOSCIENCES · Mar 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IDE161 for patients with advanced solid tumors, which are cancers that have spread beyond their original location. The goal is to find out how safe and effective IDE161 is, both on its own and when combined with another medication called pembrolizumab. The trial is currently looking for adult participants aged 18 and older who have specific types of cancer, including breast, ovarian, pancreatic, prostate, endometrial, colorectal, and head and neck cancers. To qualify, patients must have already tried at least one standard treatment that didn’t work for them.

Participants in the trial can expect to receive close monitoring throughout the study to ensure their safety and to see how well the treatment is working. It's important to note that certain conditions, such as active infections or significant heart problems, may exclude someone from participating. By joining this trial, patients have the opportunity to contribute to important research that may help improve cancer treatment options in the future.

Gender

ALL

Eligibility 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