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

Launched by TANGO THERAPEUTICS, INC. · May 24, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment combination for patients with advanced solid tumors that have a specific genetic mutation called STK11. The treatment involves a drug called TNG260, which is aimed at disrupting cancer growth, along with another medicine known as pembrolizumab, which helps the immune system fight cancer. The main goals of the trial are to find out what the best dose of TNG260 is for future studies, how safe the combination is, how the body processes TNG260, and whether it has any early signs of effectiveness against the tumors.

To participate in this trial, you need to be at least 18 years old and have a diagnosed solid tumor with the STK11 mutation. You should also be in good enough health to handle the treatment, as shown by specific health tests. If you join the trial, you will receive the study treatment until you experience side effects that are too difficult to manage, your cancer worsens, or you decide to leave the study. This trial is currently looking for participants and welcomes individuals of all genders. It’s important to note that certain health issues or ongoing treatments may prevent someone from joining, so discussing your eligibility with your healthcare provider is crucial.

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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