Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 31 May 2025
- Expected end
- December 2027
- Enrollment
- 183 participants
- Sites
- 18
- Primary outcomes
- Phase 1: Maximum Tolerated Dose; Phase 1: Maximum Tolerated Dose; Phase 2: Combination Anti-neoplastic Activity
- Sponsor
- Industry
- Results posted
- No
- Last update
- 23 October 2026
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.