Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

Prior treatment

• Currently participating in or has planned participation in a study of another investigational agent or device
• Active prior or concurrent malignancy.

Other illness

• 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
• Impairment of GI function or disease that may significantly alter the absorption of oral TNG260
• Current active liver disease from any cause
• Clinically relevant cardiovascular disease

Other

• Central nervous system metastases associated with progressive neurological symptoms
• A female patient who is pregnant or lactating

• 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