Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT05887492
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05887492
Study Brief:
Protocol Section:
NCT05887492