Clinical trialPhase 1Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 1 March 2025
- Expected end
- 1 July 2026
- Enrollment
- 18 participants
- Sites
- 1
- Primary outcomes
- dose-limiting toxicities (DLTs); treatment-emergent adverse events (TEAEs); treatment related adverse event (TRAE); immune-related Adverse Event(irAE）; Serious Adverse Event(SAE）
- Sponsor
- Other
- Results posted
- No
- Last update
- 11 August 2025
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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