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

Recruiting now · Phase 1/Phase 2

Conditions studied: PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC, RAS Mutation, MTAP Deletion, Lung Cancer, Pancreatic Cancer Metastatic, Thoracic Cancer

In brief

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.

Key facts

Study ID

NCT06922591

Run by

Tango Therapeutics, Inc.

People needed

183

Starts

2025-05-31

Expected to finish

2027-12-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is ≥18 years of age at the time of signature of the main study ICF.
• Has an ECOG PS of 0 or 1.
• Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene
• Arms A and B only: Has a tumor with a RAS mutation
• Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC
• Has received prior standard therapy
• Arms A and B only: Must not have received prior RAS-targeted therapy
• Has evidence of measurable disease based on RECIST v1.1.
• Adequate organ function
• Must be able to swallow tablets.
• Negative pregnancy test at screening
• Written informed consent must be obtained according to local guidelines

You may not qualify if…

• Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor
• Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805
• 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
• Has uncontrolled intercurrent illness that will limit compliance with the study requirements.
• Has an active infection requiring systemic therapy.
• Is currently participating in or has planned concurrent participation in a study of another investigational agent or device.
• Has impairment of GI function or disease that may significantly alter the absorption of the oral medications
• Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms
• Has current active liver disease from any cause
• Is known to be HIV positive, unless all the following criteria are met:
• CD4+ count ≥300/µL.
• Undetectable viral load.
• Receiving highly active antiretroviral therapy
• Has clinically relevant cardiovascular disease
• History of or presence of active interstitial lung disease
• Is a female patient who is pregnant or lactating
• Is unwilling or unable to comply with the scheduled visits, study treatment administration plan, laboratory tests or other study procedures and study restrictions.
• Has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion may affect the safety of the patient or impair the ability to assess study results

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States (enrolling)
• Sarah Cannon Research Institute Denver — Denver, Colorado, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• University of Indiana — Indianapolis, Indiana, United States (enrolling)
• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Dallas — Irving, Texas, United States (enrolling)
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
• NEXT Oncology — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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