Actively Recruiting
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.
Led by Shanghai JMT-Bio Inc. · Updated on 2026-01-29
436
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 clinical trial to assess JMT108 injection in adults with advanced malignant tumors. The study aims to evaluate the safety, tolerability, how the drug moves through the body, and early signs of anti-tumor activity. It focuses on patients whose tumors no longer respond to standard treatments or who have no available standard options. The trial is sponsored by Shanghai JMT-Bio Inc. and includes participants aged 18 and older. Participants will receive JMT108 or other study drugs such as Pembrolizumab or Ivonescimab through intravenous infusions every three weeks in 3-week cycles. The study includes dose-escalation and dose-expansion phases to find the recommended dose and schedule for future studies. The treatment is open-label, meaning both researchers and participants know what is being administered. During the study, participants will undergo tumor evaluations using established criteria, along with regular blood tests and physical exams to monitor organ function and side effects. Researchers will track dose-limiting toxicities for about 28 days and adverse events throughout the study, which typically lasts about one year. The trial also measures drug levels in the blood. Participants are expected to have a performance status allowing daily activities and a predicted survival of at least three months.
CONDITIONS
Brief Title
First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully informed of the study, able to comply, and willing to provide written consent.
- Male or female aged 18 years or older at consent.
- Histologically or cytologically confirmed advanced malignant tumors unresponsive or intolerant to all standard care, or no standard care available.
- For certain advanced lung cancers without gene mutations, untreated patients unwilling to accept current standard treatment can join cohort expansion.
- At least one evaluable tumor lesion for dose-escalation phase; at least one measurable lesion for dose-expansion and Phase 1b.
- ECOG performance score 2 or less for Stage I; 0 to 1 for Stage II.
- Expected survival of 3 months or more.
- Adequate organ function including blood counts, liver and kidney function, coagulation parameters, and albumin levels as specified.
You will not qualify if you...
- Use of other investigational drugs within 4 weeks before first dose.
- Recent chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before first dose, with some exceptions.
- Major surgery or severe trauma within 4 weeks before first dose or planned during study.
- Systemic corticosteroids or immunosuppressive therapy within 14 days before first dose, except for certain low-dose or topical uses.
- Live vaccines within 4 weeks before first dose, except inactivated seasonal flu vaccines.
- History of stem cell or organ transplant.
- Unresolved adverse events from prior therapies above Grade 1 or baseline.
- Active central nervous system or leptomeningeal metastases, with some exceptions.
- History of interstitial lung disease or pneumonitis.
- History of serious cardiovascular or cerebrovascular diseases.
- Active or recurrent autoimmune diseases.
- Prior severe immune-related adverse events related to immune therapies.
- Significant recent bleeding within 4 weeks before first dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive intravenous injections of JMT108, Pembrolizumab, and Ivonescimab every three weeks in 3-week cycles.
Visits every 3 weeks for administration
Duration - Up to approximately 1 year
Participants are monitored for safety and anti-tumor activity after treatment completion.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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