RecruitingPhase 1Phase 2NCT07280832

Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma

Open-Label, Multicenter Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT108 Injection in Participants With Unresectable or Metastatic Melanoma


Sponsor

Shanghai JMT-Bio Inc.

Enrollment

188 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I/II trial is testing a new immunotherapy drug called JMT108 for people with advanced or metastatic melanoma (skin cancer) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic melanoma confirmed by biopsy that cannot be removed surgically - Your melanoma has not responded to previous treatments, or no standard treatment is available - You have at least one measurable tumor on scan - You are in good physical condition (ECOG 0–1) with at least 3 months expected survival - Your organ function is adequate **You may NOT be eligible if...** - You received cancer treatment (chemo, radiation, targeted therapy, immunotherapy) within the past 4 weeks - You have previously received IL-2 or IL-15 cancer therapies - You have active or growing brain metastases (stable brain metastases are allowed) - You have active autoimmune disease - You have had a blood clot (arterial or venous thrombosis) within the past 6 months - You are on systemic steroids or immune-suppressing drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJMT108

Intravenous (IV) administration


Locations(1)

BeiJing Cancer Hospital EC

Beijing, Beijing Municipality, China

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NCT07280832