NCT06922591

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: Tango Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. 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

• PDAC
• PDAC - Pancreatic Ductal Adenocarcinoma
• NSCLC
• RAS Mutation
• MTAP Deletion
• Lung Cancer
• Pancreatic Cancer Metastatic
• Thoracic Cancer

Interventions

Type	Name	Description
DRUG	TNG462	MTA cooperative PRMT5 inhibitor
DRUG	RMC-9805	RAS(ON) G12D selective covalent inhibitor
DRUG	RMC-6236	RAS(ON) multi-selective inhibitor
DRUG	mFOLFIRINOX	Chemotherapy
DRUG	gemcitabine/nab-paclitaxel	Chemotherapy

Timeline

• Start date: 2025-05-31
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-04-10
• Last updated: 2025-12-11

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study