PARG Inhibitor IDE161 in Advanced Solid Tumors

What is the Purpose of this Study?

This study focuses on individuals who have a solid tumor cancer (not a blood cancer) that has worsened and has not responded to at least one prior cancer treatment. The purpose of the study is to evaluate the safety and effectiveness of an experimental drug called IDE161 (used alone) in solid tumors known to carry an error in genes that repair DNA. Cells have different ways to repair damaged DNA. One of these paths is called homologous recombination (HR). An error in genes that belong to HR can lead to abnormal cell growth, which can lead to cancer. Participants in this study have one or more gene mutations in HR genes, such as BRCA1 and BRCA2. IDE161 blocks the ability of a specific protein from properly functioning. Previous studies have shown that tumors with errors in the HR genes have a greater potential for responding to treatment with IDE161.

Eligibility

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)

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

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Saba Mukarram
CS Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

IDE161-001: A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors

Study Details

Disease Type/Condition

Bones and Joints, Breast, Cervix, Colon, Kidney, Liver, Lung, Melanoma, Other Female Genital, Ovary, Pancreas, Prostate

Principal Investigator

Hafez, Navid

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Justin Moyers, Kristopher Wentzel, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

IRB Number

STUDY00003043

ClinicalTrials.gov ID

NCT05787587

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Saba Mukarram

Phone

+1 310-231-2181

MukarramS@cshs.org