Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
NCT ID: NCT06922591
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
183 participants
INTERVENTIONAL
2025-05-31
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
NCT06625320
AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
NCT01024387
A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
NCT01562899
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
NCT00245362
Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
NCT04787991
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose Escalation 1A
Escalating oral doses of TNG462 in combination with oral RMC-6236
TNG462
MTA cooperative PRMT5 inhibitor
RMC-6236
RAS(ON) multi-selective inhibitor
Dose escalation 1B
Escalating oral doses of TNG462 in combination with oral RMC-9805
TNG462
MTA cooperative PRMT5 inhibitor
RMC-9805
RAS(ON) G12D selective covalent inhibitor
Dose Expansion 2A
Expansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236
TNG462
MTA cooperative PRMT5 inhibitor
RMC-6236
RAS(ON) multi-selective inhibitor
Dose Expansion 2B
Expansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805
TNG462
MTA cooperative PRMT5 inhibitor
RMC-9805
RAS(ON) G12D selective covalent inhibitor
Experimental: Dose Escalation 1C
Escalating doses of TNG462 in combination with mFOLFIRINOX
TNG462
MTA cooperative PRMT5 inhibitor
mFOLFIRINOX
Chemotherapy
Experimental: Dose Escalation 1D
Escalating doses of TNG462 in combination with gemcitabine/nab-paclitaxel
TNG462
MTA cooperative PRMT5 inhibitor
gemcitabine/nab-paclitaxel
Chemotherapy
Experimental: Dose Expansion 2C
Expansion arm at the RDE(s) of TNG462 in combination with mFOLFIRINOX
TNG462
MTA cooperative PRMT5 inhibitor
mFOLFIRINOX
Chemotherapy
Experimental: Dose Expansion 2D
Expansion arm at the RDE(s) of TNG462 in combination with gemcitabine/nab-paclitaxel
TNG462
MTA cooperative PRMT5 inhibitor
gemcitabine/nab-paclitaxel
Chemotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TNG462
MTA cooperative PRMT5 inhibitor
RMC-9805
RAS(ON) G12D selective covalent inhibitor
RMC-6236
RAS(ON) multi-selective inhibitor
mFOLFIRINOX
Chemotherapy
gemcitabine/nab-paclitaxel
Chemotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Revolution Medicines, Inc.
INDUSTRY
Tango Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maxim Pimpkin, MD, PhD
Role: STUDY_DIRECTOR
Tango Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Sarah Cannon Research Institute Denver
Denver, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Indiana
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TNG462-C102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.