Status:
RECRUITING
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
Lead Sponsor:
Tango Therapeutics, Inc.
Collaborating Sponsors:
Revolution Medicines, Inc.
Conditions:
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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, R...
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, R...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Is a female patient who is pregnant or lactating
- Is unwilling or unable to comply with the scheduled visits, study treatment administration plan, laboratory tests or other study procedures and study restrictions.
- 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
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT06922591
Start Date
May 31 2025
End Date
December 1 2027
Last Update
December 11 2025
Active Locations (12)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5452
2
Sarah Cannon Research Institute Denver
Denver, Colorado, United States, 80218
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
4
University of Indiana
Indianapolis, Indiana, United States, 46202