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RECRUITINGPHASE1/PHASE2

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

NCT06922591•Tango Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

Detailed Description

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. For the RAS inhibitor arms, the study will be conducted in patients with MTAP loss and RAS mutant metastatic pancreatic adenocarcinoma (PDAC) or locally advanced or metastatic non-small cell lung cancer (NSCLC). For the chemotherapy specific arms, the study will be conducted in patients with MTAP loss locally advanced or metastatic PDAC. The entire study (all arms) will be conducted in 2 parts: Phase 1 (dose escalation) and Phase 2 (dose expansion). Individual Arms in the dose expansion phase may open once the MTD and/or RD(s) has been determined for the corresponding combination in the dose escalation phase of the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Is ≥18 years of age at the time of signature of the main study ICF.
•2. Has an ECOG PS of 0 or 1.
•3. Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene
•4. Arms A and B only: Has a tumor with a RAS mutation
•5. Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC
•6. Has received prior standard therapy
•7. Arms A and B only: Must not have received prior RAS-targeted therapy
•8. Has evidence of measurable disease based on RECIST v1.1.
•9. Adequate organ function
•10. Must be able to swallow tablets.
+2 more criteria

Exclusion Criteria

•1. Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor
•2. Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805
•3. Known allergy, hypersensitivity or intolerance to TNG462 (all arms), RMC-6236 Arm A), RMC-9805 (Arm B), mFOLFIRINOX (Arm C), gemcitabine/nab-paclitaxel (Arm D) or their excipients
•4. Has uncontrolled intercurrent illness that will limit compliance with the study requirements.
•5. Has an active infection requiring systemic therapy.
•6. Is currently participating in or has planned concurrent participation in a study of another investigational agent or device.
•7. Has impairment of GI function or disease that may significantly alter the absorption of the oral medications
•8. Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms
•9. Has current active liver disease from any cause
•10. Is known to be HIV positive, unless all the following criteria are met:
+8 more criteria

Locations (12)

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Sarah Cannon Research Institute Denver

Denver, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

University of Indiana

Indianapolis, Indiana, 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 Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

May 31, 2025

Primary Completion Date

June 1, 2027

Completion Date

December 1, 2027

Last Updated

December 11, 2025

Enrollment

183

ESTIMATED participants

Conditions

PDACPDAC - Pancreatic Ductal AdenocarcinomaNSCLCRAS MutationMTAP DeletionLung CancerPancreatic Cancer MetastaticThoracic Cancer

Interventions

TNG462

DRUG

RMC-9805

DRUG

RMC-6236

DRUG

mFOLFIRINOX

DRUG

gemcitabine/nab-paclitaxel

DRUG

Contacts

Maxim Pimpkin, MD, PhD

CONTACT

857-320-4899 clinicaltrials@tangotx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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