RECRUITING

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

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Conditions

Advanced or Metastatic Solid TumorsBreast CancerOvarian CancerPancreas CancerProstate CancerEndometrial CancerColorectal CancerHead and Neck CancersPARPiPARP inhibitorBRCAHRD gene alterationBreastOvarianAdvanced solid tumorsMetastatic solid tumorsBRCA 1BRCA 2Homologous recombinationPARGPARG InhibitionATMBARD1BRIP1CDK12CHEK1CHEK2FANCLPALB2PPP2R2ARAD51CRAD51DRAD54LNBNFANCAHRD+EndometrialPembroPembrolizumabHR genesgenomic instability scoreGISGI+gLOHgenomic loss of heterozygosityMSSMSIMMRPD-L1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.

Official Title

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

Quick Facts

Study Start:2023-04-05
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05787587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult participants must be 18 years of age or older
  2. 2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
  3. 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)
  4. 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. 5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
  6. 6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)
  1. 1. Known primary CNS malignancy
  2. 2. Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
  3. 3. Have active, uncontrolled infection
  4. 4. Clinically significant cardiac abnormalities
  5. 5. Major surgery within 4 weeks prior to enrollment
  6. 6. Radiation therapy within 2 weeks prior to enrollment
  7. 7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
  8. 8. Radioimmunotherapy within 6 weeks of enrollment
  9. 9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment
  10. 10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter
  11. 11. Have current active liver or biliary disease
  12. 12. For Module 2 only, History or allogeneic tissue/solid organ transplant
  13. 13. For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years
  14. 14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Contacts and Locations

Study Contact

IDEAYA Clinical Trials
CONTACT
650-278-8351
IDEAYAClinicalTrials@ideayabio.com

Principal Investigator

Darrin Beaupre, MD,PhD
STUDY_DIRECTOR
IDEAYA Biosciences

Study Locations (Sites)

The Angeles Clinic
Los Angeles, California, 90025
United States
California Pacific Medical Center
San Francisco, California, 94115
United States
Sarah Cannon Research Institute
Denver, Colorado, 80218
United States
Yale University
New Haven, Connecticut, 06511
United States
Emory University
Atlanta, Georgia, 30322
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Dana Faber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
United States
Columbia University Medical Center
New York, New York, 10032
United States
Weil Cornell University
New York, New York, 10065
United States
Sarah Cannon Research Institute - Oklahoma University
Oklahoma City, Oklahoma, 73104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Sarah Cannon Research Institute - Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
MD Anderson
Houston, Texas, 77030
United States
NEXT Oncology
Irving, Texas, 75039
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
START Mountain Region
West Valley City, Utah, 84119
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: IDEAYA Biosciences

  • Darrin Beaupre, MD,PhD, STUDY_DIRECTOR, IDEAYA Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-05
Study Completion Date2027-05

Study Record Updates

Study Start Date2023-04-05
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • PARPi
  • PARP inhibitor
  • BRCA
  • HRD gene alteration
  • Breast
  • Ovarian
  • Advanced solid tumors
  • Metastatic solid tumors
  • BRCA 1
  • BRCA 2
  • Homologous recombination
  • PARG
  • PARG Inhibition
  • ATM
  • BARD1
  • BRIP1
  • CDK12
  • CHEK1
  • CHEK2
  • FANCL
  • PALB2
  • PPP2R2A
  • RAD51C
  • RAD51D
  • RAD54L
  • NBN
  • FANCA
  • HRD+
  • Endometrial
  • Pembro
  • Pembrolizumab
  • HR genes
  • genomic instability score
  • GIS
  • GI+
  • gLOH
  • genomic loss of heterozygosity
  • MSS
  • MSI
  • MMR
  • PD-L1

Additional Relevant MeSH Terms

  • Advanced or Metastatic Solid Tumors
  • Breast Cancer
  • Ovarian Cancer
  • Pancreas Cancer
  • Prostate Cancer
  • Endometrial Cancer
  • Colorectal Cancer
  • Head and Neck Cancers