Phase
Condition
Breast Cancer
Prostate Cancer
Colorectal Cancer
Treatment
IDE-161
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 alterationsconferring 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 theadvanced 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 carcinosarcomais excluded)
For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonalantibody (MAB)
Exclusion
Exclusion Criteria:
Known primary CNS malignancy
Impairment of GI function or GI disease that may significantly alter the absorptionof 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 inpast 2 years
For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung diseasethat required steroids or has current pneumonitis/interstitial lung disease
Study Design
Study Description
Connect with a study center
HonorHealth Research Institute
Phoenix, Arizona 85027
United StatesActive - Recruiting
University of Arizona Cancer Center
Tucson, Arizona 85719
United StatesSite Not Available
The Angeles Clinic
Los Angeles, California 90025
United StatesActive - Recruiting
Hoag Memorial Hospital
Newport Beach, California 92663
United StatesActive - Recruiting
California Pacific Medical Center
San Francisco, California 94115
United StatesActive - Recruiting
Sarah Cannon Research Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06511
United StatesActive - Recruiting
Orlando Health
Orlando, Florida 32806
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
OSF St Francis Medical Center
Peoria, Illinois 61637
United StatesActive - Recruiting
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Dana Faber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United StatesActive - Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Weil Cornell University
New York, New York 10065
United StatesActive - Recruiting
Sarah Cannon Research Institute
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Sarah Cannon Research Institute - Oklahoma University
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Sarah Cannon Research Institute
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Sarah Cannon Research Institute - Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
MD Anderson
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology
Irving, Texas 75039
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
START Mountain Region
West Valley City, Utah 84119
United StatesActive - Recruiting
NEXT Oncology
Fairfax, Virginia 22031
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle, Washington 98104
United StatesActive - Recruiting
University of Wisconsin
Madison, Wisconsin 53792
United StatesActive - Recruiting
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