RecruitingPhase 1Phase 2NCT06922591

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic Cancer With MTAP Loss and Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation

Sponsor

Tango Therapeutics, Inc.

Enrollment

183 participants

Start Date

May 31, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer NSCLC Thoracic Cancer PDAC PDAC - Pancreatic Ductal Adenocarcinoma RAS Mutation MTAP Deletion Pancreatic Cancer Metastatic

Summary

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TNG462 — a PRMT5 inhibitor — in combination with other targeted therapies for people with advanced pancreatic cancer or non-small cell lung cancer whose tumors have a specific genetic deletion (loss of MTAP) and RAS mutations. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic pancreatic cancer or advanced/metastatic non-small cell lung cancer - Your tumor has lost the MTAP protein or has a bi-allelic MTAP gene deletion - Your tumor has a RAS mutation (for most study arms) - You have received prior standard therapy - You can swallow tablets **You may NOT be eligible if...** - You have previously received a PRMT5 inhibitor or MAT2A inhibitor - You have previously received RAS-targeted therapy (for certain study arms) - You have uncontrolled medical conditions or poor organ function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTNG462

MTA cooperative PRMT5 inhibitor

DRUGRMC-9805

RAS(ON) G12D selective covalent inhibitor

DRUGRMC-6236

RAS(ON) multi-selective inhibitor

DRUGmFOLFIRINOX

Chemotherapy

DRUGgemcitabine/nab-paclitaxel

Chemotherapy

Locations(18)

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Sarah Cannon Research Institute Denver

Denver, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Indiana

Indianapolis, Indiana, United States

University of Iowa Health Care

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Dallas

Irving, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

NEXT Oncology

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06922591

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