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. Have documented evidence of genetic alterations conferring homologous recombination deficiency
  • 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
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Where can I participate?

  • Cedars-Sinai Cancer at SOCC
  • Cedars-Sinai Cancer at The Angeles Clinic and Research Institute


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

I

IRB Number

STUDY00003043

ClinicalTrials.gov ID

NCT05787587

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

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

Principal Investigator

Hafez, Navid

Age Group

Adult

Phase

I

IRB Number

IDE161-001

ClinicalTrials.gov ID

NCT05787587

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org