Phase
Condition
Vaginal Cancer
Pelvic Cancer
Ovarian Cancer
Treatment
NKT5097 CDK2/CDK4 dual degrader
Fulvestrant
Letrozole
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to provide written informed consent
Advanced unresectable or metastatic solid tumor (Part 1, 2 & 3 only)
Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 & 5 only)
Refractory to or unable to tolerate existing therapies (Part 1, 2 & 4 only)
Measurable or evaluable disease (Part 1, 2, & 4 only).
Measurable disease (Part 3 & 5 only)
Eighteen years of age or older
ECOG status of 0 or 1
Adequate organ function
Patients with female reproductive organs must be surgically sterile, post-menopausal or willing to use effective contraception per protocol
Patients who are capable of insemination must be willing to use highly effectivecontraception and to refrain from sperm donation during treatment and for 28 daysafter the last dose
Able to swallow oral meds
Willing to provide tumor tissue
Exclusion
Exclusion Criteria:
Advanced solid tumor that is a candidate for curative treatment
History of another malignancy except for the following: adequately treated localbasal cell or squamous carcinoma of the skin, in situ cervical cancer, adequatelytreated papillary noninvasive bladder cancer, other adequately treated Stage I orStage II cancers currently in complete remission
Not recovered from the effects of prior anticancer therapy
Clinically significant cardiovascular event, including myocardial infarction,arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
Known active CNS metastases and/or carcinomatous meningitis
Active interstitial lung disease requiring treatment
History of uveitis, retinopathy, or other clinically significant retinal disease
Major surgery within 30 days of administration of first dose
Active uncontrolled infectious disease
Significant liver disease (Child Pugh class B or C)
Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)
Study Design
Study Description
Connect with a study center
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
UC San Diego Moores Cancer Center
La Jolla, California 92037
United StatesActive - Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06520
United StatesActive - Recruiting
SCRI Florida Cancer Specialists - Sarasota
Sarasota, Florida 34232
United StatesActive - Recruiting
University of Iowa
Iowa City, Iowa 52242
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02115
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Washington University
St Louis, Missouri 63110
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah 84119
United StatesActive - Recruiting
NEXT Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26506
United StatesActive - Recruiting

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