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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic Scottsdale
RECRUITING
Scottsdale
Colorado
Sarah Cannon Research Institute Denver
RECRUITING
Denver
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Indiana
University of Indiana
RECRUITING
Indianapolis
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Minnesota
Mayo Clinic Cancer Center
RECRUITING
Rochester
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
NEXT Dallas
RECRUITING
Irving
Virginia
NEXT Oncology
RECRUITING
Fairfax
Contact Information
Primary
Maxim Pimpkin, MD, PhD
clinicaltrials@tangotx.com
857-320-4899
Time Frame
Start Date: 2025-05-31
Estimated Completion Date: 2027-12
Participants
Target number of participants: 183
Treatments
Experimental: Dose Escalation 1A
Escalating oral doses of TNG462 in combination with oral RMC-6236
Experimental: Dose escalation 1B
Escalating oral doses of TNG462 in combination with oral RMC-9805
Experimental: Dose Expansion 2A
Expansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236
Experimental: Dose Expansion 2B
Expansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805
Experimental: Experimental: Dose Escalation 1C
Escalating doses of TNG462 in combination with mFOLFIRINOX
Experimental: Experimental: Dose Escalation 1D
Escalating doses of TNG462 in combination with gemcitabine/nab-paclitaxel
Experimental: Experimental: Dose Expansion 2C
Expansion arm at the RDE(s) of TNG462 in combination with mFOLFIRINOX
Experimental: Experimental: Dose Expansion 2D
Expansion arm at the RDE(s) of TNG462 in combination with gemcitabine/nab-paclitaxel
Sponsors
Leads: Tango Therapeutics, Inc.
Collaborators: Revolution Medicines, Inc.

This content was sourced from clinicaltrials.gov