drugset / Trial / 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)
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2025-03-01
- Primary completion
- 2025-12-01
- Completion
- 2026-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TMT101 | Unknown | 0.1 mg | Intramuscular |
| Subject | TMT101 | Unknown | 0.2 mg | Intramuscular |
| Subject | TMT101 | Unknown | 0.4 mg | Intramuscular |