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
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Agrees to follow the trial protocol and visit schedule, has signed informed consent;

• Subjects must be ≥18 years of age at time of informed consent,regardless of gender;

• Patients with advanced/unresectable or metastatic pancreatic cancer or non-small cell lung cancer that requires histologically and/or cytologically confirmed according to the American Joint Committee on Cancer 8th edition; pancreatic cancer:Previous failure or intolerance of two or more lines of chemotherapy; NSCLC:Previous failure or intolerance of platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibodies, regardless of combination therapy or sequential therapy, if the previous test for EGFR-sensitive mutations or ALK fusion genes is positive, treatment with a third-generation TKI must be failed or intolerant;

• At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;

• ECOG≤1;

• Estimated life expectancy≥12 weeks;

• Adequate organ function, meet the following laboratory standards:

‣ ANC≥1.5×109/L;PLT≥90×109/L;

⁃ Hb≥90 g/L;

⁃ TBIL≤1.5×ULN, Patients with Gilbert's syndrome ; without liver metastases, AST and ALT ≤ 2.5×ULN;liver metastases, AST and ALT ≤5×ULN ;

⁃ Ccr≥50 mL/min;

⁃ INR≤1.5×ULN, APTT≤1.5×ULN;

• Males of childbearing potential and females of childbearing potential who are willing to use effective contraception since signing the informed consent until 6 months after the last dose of the trial drug. Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Wenming Wu, PhD
pumchkyc@126.com
010-69156874
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 18
Treatments
Experimental: TMT101 Injection monotherapy
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
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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