A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Antitumor Activity of JMT106 Injection in Patients With Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors

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

• Age ≥18 years.

• Histologically or cytologically confirmed advanced solid tumor.

• Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment at the current stage.

• At least one measurable lesion according to RECIST 1.1 criteria.

• ECOG performance status of 0-1.

• Expected survival ≥3 months.

• Sufficient organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factor treatment within 14 days):

‣ Absolute neutrophil count (ANC) ≥1.5×10⁹/L;

⁃ Platelets (PLT) ≥90×10⁹/L;

⁃ Hemoglobin (Hb) ≥90 g/L;

⁃ Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for liver metastases or hepatocellular carcinoma);

⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for liver metastases or hepatocellular carcinoma);

⁃ Creatinine clearance (Ccr) \>50 mL/min (calculated by Cockcroft-Gault formula);

⁃ Activated partial thromboplastin time (APTT) ≤1.5×ULN; INR ≤1.5×ULN.

• Fertile participants (male and female) must agree to use reliable contraception (hormonal, barrier, or abstinence) with their partners during the trial and for at least 180 days after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.

• Understand and voluntarily sign the informed consent form (ICF).

Locations
Other Locations
China
The First Affilicated Hospital,Zhejiang University School of Medicine
RECRUITING
Zhejiang
Contact Information
Primary
Liang Ting bo, Ph.D
liangtingbo@zju.edu.cn
0571-87236666
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2028-11-15
Participants
Target number of participants: 200
Treatments
Experimental: JMT106 injection as single agent
Related Therapeutic Areas
Sponsors
Leads: Shanghai JMT-Bio Inc.

This content was sourced from clinicaltrials.gov

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