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Clinical Trial Record

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

2025-05-31

2027-06

2027-12

133

Study Overview

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

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 or RMC-9805. The study comprises a dose escalation phase and a dose expansion phase.

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 or RMC-9805. 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) 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.

  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • NSCLC
  • RAS Mutation
  • MTAP Deletion
  • Lung Cancer
  • Pancreatic Cancer Metastatic
  • Thoracic Cancer
  • DRUG: TNG462
  • DRUG: RMC-9805
  • DRUG: RMC-6236
  • TNG462-C102

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-03-28  

N/A  

2025-06-12  

2025-04-03  

N/A  

2025-06-13  

2025-04-10  

N/A  

2025-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dose Escalation 1A

Escalating oral doses of TNG462 in combination with oral RMC-6236

DRUG: TNG462

  • MTA cooperative PRMT5 inhibitor

DRUG: RMC-6236

  • RAS(ON) multi-selective inhibitor
EXPERIMENTAL: Dose escalation 1B

Escalating oral doses of TNG462 in combination with oral RMC-9805

DRUG: TNG462

  • MTA cooperative PRMT5 inhibitor

DRUG: RMC-9805

  • RAS(ON) G12D selective covalent inhibitor
EXPERIMENTAL: Dose Expansion 2A

Expansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236

DRUG: TNG462

  • MTA cooperative PRMT5 inhibitor

DRUG: RMC-6236

  • RAS(ON) multi-selective inhibitor
EXPERIMENTAL: Dose Expansion 2B

Expansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805

DRUG: TNG462

  • MTA cooperative PRMT5 inhibitor

DRUG: RMC-9805

  • RAS(ON) G12D selective covalent inhibitor
Primary Outcome MeasuresMeasure DescriptionTime Frame
Phase 1: Maximum Tolerated DoseTo determine the MTD and RD(s) of TNG462 in combination with RMC-6236 or RMC-980521 days
Phase 2: Combination Anti-neoplastic ActivityTo assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236 or RMC-9805 using RECIST 1.19 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Phase 1: Combination Anti-neoplastic ActivityTo assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236 or RMC-9805 using RECIST 1.19 weeks
Phase 1 and 2: Cmax of TNG462 and in CombinationTo characterize the Cmax of TNG462 in combination with RMC-6236 or RMC-980521 days
Phase 1 and 2: Tmax of TNG462 and in CombinationTo characterize the Tmax of TNG462 in combination with RMC-6236 or RMC-980521 days
Phase 1 and 2: AUC of TNG462 and in CombinationTo characterize the AUC of TNG462 and in combination with RMC-6236 or RMC-980521 days
Phase 1 and 2 Adverse Event ProfileTo determine the safety and tolerability of TNG462 in combination with RMC-6236 or RMC-980521 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Maeve Waldron-Lynch, MD

Phone Number: 857-320-4899

Email: clinicaltrials@tangotx.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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. 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. 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. 11. Negative pregnancy test at screening 12. Written informed consent must be obtained according to local guidelines
    Exclusion Criteria:
    1. Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor 2. Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805 3. Known allergy, hypersensitivity or intolerance to TNG462, RMC-6236, RMC-9805 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:
    1. CD4+ count ≥300/µL. 2. Undetectable viral load. 3. Receiving highly active antiretroviral therapy 11. Has clinically relevant cardiovascular disease 12. History of or presence of active interstitial lung disease 13. Is a female patient who is pregnant or lactating 14. Is unwilling or unable to comply with the scheduled visits, study treatment administration plan, laboratory tests or other study procedures and study restrictions. 15. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Revolution Medicines, Inc.
  • STUDY_DIRECTOR: Maeve Waldron-Lynch, MD, Tango Therapeutics, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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