NCT06861543

The Purpose of This Study is to Evaluate the Safety, Tolerability and Efficacy of TMT101 Injection Monotherapy in Patients With Advanced Pancreatic Cancer or Non-small Cell Lung Cancer(NSCLC)

A Single Arm, Open Label, Dose-escalating, Prospective Phase I Clinical Trial Evaluating the Safety, Tolerability and Efficacy of TMT101 Injection Alone in Patients With Advanced Pancreatic Cancer or Non-small Cell Lung Cancer(NSCLC) After Standard Treatment Failure

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, single-arm, open-label, dose escalation prospective phase I clinical study to evaluate the Safety, Tolerability and Efficacy of TMT101 Injection Alone in patients with Unresectable, Metastatic or Advanced pancreatic cancer or Non-small Cell Lung Cancer(NSCLC) after Standard Treatment Failure. The primary objective is to evaluate the safety and tolerability of TMT101 Injection as monotherapy in patients with advanced pancreatic cancer and NSCLC, and to determine the recommended therapeutic dose (RD) of TMT101 Injection as monotherapy

Detailed description

The dose escalation trial adopts the "3+3" design , and about 3\~6 patients with advanced pancreatic cancer or non-small cell lung cancer are enrolled in each dose level to evaluate the safety of TMT101 Injection alone. Three dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. Once a week, intramuscular Injection , a total of 9 times (the first tumor assessment is performed in the 6th week (±7 days), the investigator can decide the follow-up medication arrangement according to the tumor evaluation results). Dose-limiting toxicities (DLTs) will be assessed for each dose level, and the DLT observation period will be within 21 days from the first dose. The initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. If the highest dose level of 0.4 mg is not confirmed as a possible recommended therapeutic dose (RD), it may be escalated a higher dose to determine the possible RD under the condition that investigator and the sponsor to decide together

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TMT101 Injection	Three dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. The initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. TMT101 will be injected intramuscularly, Once a week,a total of 9 times

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-01
• Completion: 2026-07-01
• First posted: 2025-03-06
• Last updated: 2025-08-11

Locations

1 site across 1 country: China