Actively Recruiting
First-in-Human Investigation 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
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.
CONDITIONS
Official Title
First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and willing to comply with study requirements
- Male or female aged 18 years or older
- Histologically or cytologically confirmed advanced malignant tumors unresponsive or intolerant to all standard treatments, or no available standard care
- For advanced NSCLC without sensitive gene mutations, untreated systemic advanced stage patients unwilling to accept standard treatment may enroll in cohort expansion
- At least one evaluable tumor lesion for dose-escalation phase; at least one measurable lesion for dose-expansion and Phase 1b according to RECIST v1.1
- ECOG performance status 4 for Stage I and 0-1 for Stage II
- Expected survival of 3 months or more
- Adequate organ function including hematology, liver, kidney, coagulation, and albumin levels as specified
You will not qualify if you...
- Use of unapproved investigational drugs or treatments within 4 weeks before first dose
- Received 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 major surgery during study
- Systemic corticosteroids or immunosuppressive therapy within 14 days before first dose except low-dose or topical treatments
- Live vaccines within 4 weeks before first dose, except inactivated seasonal influenza vaccines
- History of hematopoietic stem cell or organ transplant
- Unresolved adverse events from prior therapies above Grade 1 or baseline except certain low-risk toxicities
- Active central nervous system or leptomeningeal metastases unless stable for at least 4 weeks
- History of interstitial lung disease or pneumonitis
- History of serious cardiovascular or cerebrovascular diseases
- Active or recurrent autoimmune diseases
- History of severe immune-related adverse events or myocarditis related to prior immune therapy
- Significant hemorrhage within 4 weeks before first dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
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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