Phase
Condition
Cervical Cancer
Breast Cancer
Pelvic Cancer
Treatment
TNG260
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is ≥18 years of age at the time of signature of the main study ICF.
Has ECOG performance status of 0 or 1.
Has measurable disease based on RECIST v1.1.
All participants must have documented STK11 mutation in a solid tumor, which isidentified through a validated analytical method
Has confirmed histologic or cytologic diagnosis of a locally advanced or metastaticsolid tumor.
Adequate organ function/reserve per local labs
Adequate liver function per local labs
Adequate renal function per local labs
Negative serum pregnancy test result at screening
Written informed consent must be obtained according to local guidelines
Exclusion
Exclusion Criteria:
Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or itsexcipients
Uncontrolled intercurrent illness that will limit compliance with the studyrequirements
Active infection requiring systemic therapy
Currently participating in or has planned participation in a study of anotherinvestigational agent or device
Impairment of GI function or disease that may significantly alter the absorption oforal TNG260
Active prior or concurrent malignancy.
Central nervous system metastases associated with progressive neurological symptoms
Current active liver disease from any cause
Clinically relevant cardiovascular disease
A female patient who is pregnant or lactating
Study Design
Study Description
Connect with a study center
UCLA Hematology/Oncology
Santa Monica, California 90404
United StatesActive - Recruiting
SCRI at HealthOne
Denver, Colorado 80218
United StatesActive - Recruiting
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Henry Ford Health System
Detroit, Michigan 48202
United StatesActive - Recruiting
START MidWest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
New York University Langone Health
New York, New York 10016
United StatesActive - Recruiting
Sarah Cannon Tennessee Oncology
Nashville, Tennessee 37203
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology
Fairfax, Virginia 22031
United StatesActive - Recruiting
NEXT Oncology Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
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