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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)

NCT06861543 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-08-11

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Wenming Wu, PhD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-12-01
Completion
2026-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861543 on ClinicalTrials.gov