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
1 other identifier
interventional
183
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedStudy Start
First participant enrolled
May 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 22, 2026
April 1, 2026
2 years
March 28, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phase 1: Maximum Tolerated Dose
To determine the MTD and RD(s) of TNG462 in combination with RMC-6236 or RMC-9805
21 days
Phase 1: Maximum Tolerated Dose
To determine the MTD and RD(s) of TNG462 in combination with mFOLFIRINOX or gemcitabine/nab-paclitaxel
28 days
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
12 weeks
Secondary Outcomes (9)
Phase 1: Combination Anti-neoplastic Activity
12 weeks
Phase 1 and 2: Tmax of TNG462 and in Combination
21 days
Phase 1 and 2: Tmax of TNG462 and in Combination
28 days
Phase 1 and 2: Cmax of TNG462 and in Combination
21 days
Phase 1 and 2: Cmax of TNG462 and in Combination
28 days
- +4 more secondary outcomes
Study Arms (8)
Dose Escalation 1A
EXPERIMENTALEscalating oral doses of TNG462 in combination with oral RMC-6236
Dose escalation 1B
EXPERIMENTALEscalating oral doses of TNG462 in combination with oral RMC-9805
Dose Expansion 2A
EXPERIMENTALExpansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236
Dose Expansion 2B
EXPERIMENTALExpansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805
Experimental: Dose Escalation 1C
EXPERIMENTALEscalating doses of TNG462 in combination with mFOLFIRINOX
Experimental: Dose Escalation 1D
EXPERIMENTALEscalating doses of TNG462 in combination with gemcitabine/nab-paclitaxel
Experimental: Dose Expansion 2C
EXPERIMENTALExpansion arm at the RDE(s) of TNG462 in combination with mFOLFIRINOX
Experimental: Dose Expansion 2D
EXPERIMENTALExpansion arm at the RDE(s) of TNG462 in combination with gemcitabine/nab-paclitaxel
Interventions
MTA cooperative PRMT5 inhibitor
Chemotherapy
Eligibility Criteria
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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Revolution Medicines, Inc.collaborator
- Tango Therapeutics, Inc.lead
Study Sites (18)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5452, United States
Sarah Cannon Research Institute Denver
Denver, Colorado, 80218, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611-2908, United States
University of Indiana
Indianapolis, Indiana, 46202, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68124, United States
NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 11065, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7305, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
NEXT Dallas
Irving, Texas, 74039, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
NEXT Oncology
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maxim Pimpkin, MD, PhD
Tango Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 10, 2025
Study Start
May 31, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04