Actively Recruiting
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
Led by Tango Therapeutics, Inc. · Updated on 2026-05-14
183
Participants Needed
18
Research Sites
130 weeks
Total Duration
On this page
Sponsors
T
Tango Therapeutics, Inc.
Lead Sponsor
R
Revolution Medicines, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of consent
- ECOG performance status of 0 or 1
- Tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene
- For Arms A and B: tumor with a RAS mutation
- Pathologically confirmed metastatic PDAC or locally advanced, recurrent, or metastatic NSCLC
- Prior standard therapy received
- For Arms A and B: no prior RAS-targeted therapy
- Measurable disease based on RECIST v1.1
- Adequate organ function
- Ability to swallow tablets
- Negative pregnancy test at screening
- Written informed consent obtained according to local guidelines
You will not qualify if you...
- Prior treatment with a PRMT5 inhibitor or MAT2A inhibitor
- For Arms A and B: prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805
- Known allergy or intolerance to TNG462, RMC-6236, RMC-9805, mFOLFIRINOX, gemcitabine/nab-paclitaxel, or their excipients
- Uncontrolled illness limiting study compliance
- Active infection requiring systemic therapy
- Current participation in another investigational study
- Gastrointestinal impairment affecting oral drug absorption
- Active or untreated CNS metastases with neurological symptoms
- Active liver disease
- HIV positive unless criteria (CD4+ ≥300/μL, undetectable viral load, on HAART) are met
- Clinically relevant cardiovascular disease
- History or presence of active interstitial lung disease
- Pregnant or lactating female
- Unwilling or unable to comply with study visits, treatments, tests, or restrictions
- Prior or ongoing significant illness or condition affecting safety or study assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5452
Actively Recruiting
2
Sarah Cannon Research Institute Denver
Denver, Colorado, United States, 80218
Actively Recruiting
3
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611-2908
Actively Recruiting
6
University of Indiana
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
11
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68124
Actively Recruiting
12
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
13
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 11065
Actively Recruiting
14
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7305
Actively Recruiting
15
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
NEXT Dallas
Irving, Texas, United States, 74039
Actively Recruiting
17
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
M
Maxim Pimpkin, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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