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

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 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