Phase
Condition
Colorectal Cancer
Pelvic Cancer
Digestive System Neoplasms
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 StatesSite Not Available
University of Arizona Cancer Center
Tucson, Arizona 85719
United StatesSite Not Available
HonorHealth Research Institute
Phoenix 5308655, Arizona 5551752 85027
United StatesSite Not Available
The Angeles Clinic
Los Angeles, California 90025
United StatesSite Not Available
Hoag Memorial Hospital
Newport Beach, California 92663
United StatesSite Not Available
California Pacific Medical Center
San Francisco, California 94115
United StatesSite Not Available
The Angeles Clinic
Los Angeles 5368361, California 5332921 90025
United StatesActive - Recruiting
Hoag Memorial Hospital
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
California Pacific Medical Center
San Francisco 5391959, California 5332921 94115
United StatesSite Not Available
Sarah Cannon Research Institute
Denver, Colorado 80218
United StatesSite Not Available
Sarah Cannon Research Institute
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06511
United StatesSite Not Available
Yale University
New Haven 4839366, Connecticut 4831725 06511
United StatesActive - Recruiting
Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
Orlando Health
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
OSF St Francis Medical Center
Peoria, Illinois 61637
United StatesSite Not Available
OSF St Francis Medical Center
Peoria 4905687, Illinois 4896861 61637
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University
Indianapolis 4259418, Indiana 4921868 46202
United StatesCompleted
Dana Faber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Faber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89169
United StatesSite Not Available
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 StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638 14203
United StatesCompleted
Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesCompleted
Weil Cornell University
New York 5128581, New York 5128638 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 StatesSite Not Available
Sarah Cannon Research Institute - Oklahoma University
Oklahoma City 4544349, Oklahoma 4544379 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 StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Sarah Cannon Research Institute - Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
MD Anderson
Houston, Texas 77030
United StatesSite Not Available
NEXT Oncology
Irving, Texas 75039
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
MD Anderson
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
NEXT Oncology
Irving 4700168, Texas 4736286 75039
United StatesActive - Recruiting
NEXT Oncology
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
START Mountain Region
West Valley City, Utah 84119
United StatesSite Not Available
START Mountain Region
West Valley City 5784607, Utah 5549030 84119
United StatesActive - Recruiting
NEXT Oncology
Fairfax, Virginia 22031
United StatesSite Not Available
NEXT Oncology
Fairfax 4758023, Virginia 6254928 22031
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle, Washington 98104
United StatesSite Not Available
Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792
United StatesActive - Recruiting

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