Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
Non Small Cell Lung Cancer, Solid Tumors, Adult, Endometrial Cancer
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring STK11, KRAS, LKB1
Eligibility Criteria
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 is identified through a validated analytical method Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid 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 Criteria: Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients Uncontrolled intercurrent illness that will limit compliance with the study requirements Active infection requiring systemic therapy Currently participating in or has planned participation in a study of another investigational agent or device Impairment of GI function or disease that may significantly alter the absorption of oral 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
Sites / Locations
- SCRI at HealthOneRecruiting
- Florida Cancer SpecialistsRecruiting
- Dana Farber Cancer InstituteRecruiting
- New York University Langone HealthRecruiting
- Sarah Cannon Tennessee OncologyRecruiting
- NEXT OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Dose Escalation
Dose Expansion in NSCLC with KRAS Mutation
Dose Expansion in NSCLC with KRAS Wild type
Dose Expansion in Advanced or Metastatic Solid Tumors
Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD
Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab
Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab
Participants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab