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RecruitingNCT06922591Updated May 14, 2026

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

A Phase 1/2 interventional study of TNG462 and RMC-9805 in PDAC, PDAC - Pancreatic Ductal Adenocarcinoma and NSCLC, sponsored by Tango Therapeutics, Inc.. Recruiting at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Tango Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
183
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • PRMT5 inhibitor
  • RAS G12D
  • Multi RAS
  • RMC-9805
  • RMC-6236
  • Thoracic
  • Targeted therapy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 183 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Tango Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
  11. Negative pregnancy test at screening
  12. Written informed consent must be obtained according to local guidelines

Exclusion 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:

    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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
183 participants (estimated)

Study arms

  • Experimental
    Dose Escalation 1A

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

    Drug: TNG462 · Drug: RMC-6236

  • Experimental
    Dose escalation 1B

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

    Drug: TNG462 · Drug: RMC-9805

  • Experimental
    Dose Expansion 2A

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

    Drug: TNG462 · Drug: RMC-6236

  • Experimental
    Dose Expansion 2B

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

    Drug: TNG462 · Drug: RMC-9805

  • Experimental
    Experimental: Dose Escalation 1C

    Escalating doses of TNG462 in combination with mFOLFIRINOX

    Drug: TNG462 · Drug: mFOLFIRINOX

  • Experimental
    Experimental: Dose Escalation 1D

    Escalating doses of TNG462 in combination with gemcitabine/nab-paclitaxel

    Drug: TNG462 · Drug: gemcitabine/nab-paclitaxel

  • Experimental
    Experimental: Dose Expansion 2C

    Expansion arm at the RDE(s) of TNG462 in combination with mFOLFIRINOX

    Drug: TNG462 · Drug: mFOLFIRINOX

  • Experimental
    Experimental: Dose Expansion 2D

    Expansion arm at the RDE(s) of TNG462 in combination with gemcitabine/nab-paclitaxel

    Drug: TNG462 · Drug: gemcitabine/nab-paclitaxel

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

06

What researchers measure

Primary outcomes

  1. Phase 1: Maximum Tolerated Dose

    To determine the MTD and RD(s) of TNG462 in combination with RMC-6236 or RMC-9805

    Time frame: 21 days

  2. Phase 1: Maximum Tolerated Dose

    To determine the MTD and RD(s) of TNG462 in combination with mFOLFIRINOX or gemcitabine/nab-paclitaxel

    Time frame: 28 days

  3. Phase 2: Combination Anti-neoplastic Activity

    To assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel using RECIST 1.1

    Time frame: 12 weeks

Secondary outcomes

  1. Phase 1: Combination Anti-neoplastic Activity

    To assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX, or gemcitabine/nab paclitaxel using RECIST 1.1

    Time frame: 12 weeks

  2. Phase 1 and 2: Tmax of TNG462 and in Combination

    To characterize the Tmax of TNG462 in combination with RMC-6236 or RMC-9805

    Time frame: 21 days

  3. Phase 1 and 2: Tmax of TNG462 and in Combination

    To characterize the Tmax of TNG462 in combination with mFOLFIRINOX, or gemcitabine/nab-paclitaxel

    Time frame: 28 days

  4. Phase 1 and 2: Cmax of TNG462 and in Combination

    To characterize the Cmax of TNG462 in combination with RMC-6236 or RMC-9805

    Time frame: 21 days

  5. Phase 1 and 2: Cmax of TNG462 and in Combination

    To characterize the Cmax of TNG462 in combination with mFOLFIRINOX, or gemcitabine/nab-paclitaxel

    Time frame: 28 days

  6. Phase 1 and 2: AUC of TNG462 and in Combination

    To characterize the AUC of TNG462 and in combination with RMC-6236 or RMC-9805

    Time frame: 21 days

  7. Phase 1 and 2: AUC of TNG462 and in Combination

    To characterize the AUC of TNG462 in combination with mFOLFIRINOX, or gemcitabine/nab-paclitaxel

    Time frame: 28 days

  8. Phase 1 and 2 Adverse Event Profile

    To determine the safety and tolerability of TNG462 in combination with RMC-6236 or RMC-9805

    Time frame: 21 days

  9. Phase 1 and 2 Adverse Event Profile

    To determine the safety and tolerability of TNG462 in combination with mFOLFIRINOX or gemcitabine nab-paclitaxel

    Time frame: 28 days

07

Study locations

18 of 18 sites recruiting
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259-5452, United States
    • Mitesh Borad, MD · Principal investigator
    Recruiting
  • Sarah Cannon Research Institute Denver
    Denver, Colorado 80218, United States
    • Gerald Falchook, MD, MS · Principal investigator
    Recruiting
  • Georgetown University Medical Center
    Washington D.C., District of Columbia 20007, United States
    • Marcus Noel, MD · Principal investigator
    Recruiting
  • Mayo Clinic Jacksonville
    Jacksonville, Florida 32224, United States
    • Hani Babiker, MD · Principal investigator
    Recruiting
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611-2908, United States
    • Chengwei Peng, MD · Principal investigator
    Recruiting
  • University of Indiana
    Indianapolis, Indiana 46202, United States
    • Anita Turk, MD · Principal investigator
    Recruiting
  • University of Iowa Health Care
    Iowa City, Iowa 52242, United States
    • Naomi Fei, MD, MS · Principal investigator
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    • Harshabad Singh, MD · Principal investigator
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
    • Kimberly Perez, MD · Principal investigator
    Recruiting
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905-0001, United States
    • Kaushal Parikh, MD · Principal investigator
    Recruiting
  • Nebraska Cancer Specialists
    Omaha, Nebraska 68124, United States
    • Joel Michalski, MD, PhD · Principal investigator
    Recruiting
  • NYU Langone Health
    New York, New York 10016, United States
    • Kristen Spencer, DO, MPH · Principal investigator
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 11065, United States
    • Eileen O'Reilly, MD · Principal investigator
    Recruiting
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599-7305, United States
    • Shetal Patel, MD, PhD · Principal investigator
    Recruiting
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    • Jordi Rodon Ahnert, MD · Principal investigator
    Recruiting
  • NEXT Dallas
    Irving, Texas 74039, United States
    • Siraj Sen, MD · Principal investigator
    Recruiting
  • Huntsman Cancer Institute, University of Utah
    Salt Lake City, Utah 84112, United States
    • Vaia Florou, MD, MS · Principal investigator
    Recruiting
  • NEXT Oncology
    Fairfax, Virginia 22031, United States
    • Alexander Spira, MD, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06922591
Lead sponsor
Tango Therapeutics, Inc.
Collaborators
Revolution Medicines, Inc.
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
May 31, 2025
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 14, 2026

Study contacts

Maxim Pimpkin, MD, PhD
Contact
clinicaltrials@tangotx.com
857-320-4899
Maxim Pimpkin, MD, PhD
study director · Tango Therapeutics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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