Actively Recruiting
Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma
Led by Shanghai JMT-Bio Inc. · Updated on 2026-01-07
188
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of JMT108 Injection in this population. The study consists of Phase I and Phase II (including Phase IIa and Phase IIb), where Phase I is the dose-escalation stage, Phase IIa is the dose-expansion stage, and Phase IIb is the cohort-expansion stage.
CONDITIONS
Official Title
Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma
- For Phase I and IIa: participants who failed prior standard treatment or have no available standard treatment
- For Phase IIb: participants with or without prior standard treatment
- At least one measurable lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
- Expected survival of 3 months or more
- Adequate organ function
- Female and male patients of childbearing potential must agree to use adequate contraception during and for 6 months after the study; female participants must have a negative pregnancy test within 7 days before first dose
- Voluntary agreement to participate and signed informed consent
You will not qualify if you...
- Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other unapproved treatments within 4 weeks before first study drug administration
- Prior use of IL-2/IL-15 cytokine therapy
- Major organ surgery (excluding needle biopsy) or severe trauma within 4 weeks before first study drug administration, or need for elective surgery during the study
- Received systemic glucocorticoids or other immunosuppressive therapy within 14 days before first study drug use, except physiological replacement doses or certain topical or short-course glucocorticoids
- Known active central nervous system metastases or leptomeningeal metastases; stable brain metastases not requiring local treatment are allowed
- Active infections requiring intravenous anti-infective therapy within 14 days before first study drug administration
- History of severe cardiovascular or cerebrovascular diseases
- Active or recurrent autoimmune diseases
- History of immunotherapy with grade 3 or higher immune-related adverse events or grade 2 or higher immune-related myocarditis
- History of arterial or venous thrombosis within 6 months before first study drug administration
- History of serous effusions requiring drainage within 14 days before first study drug administration
- History of other malignant tumors within 5 years before first study drug administration or concurrent other malignant tumors
AI-Screening
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Trial Site Locations
Total: 1 location
1
BeiJing Cancer Hospital EC
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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