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Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors

StatusRecruiting
PhasePhase 1/2
Started2025-12-17
View on ClinicalTrials.gov ↗

Amendment history

2026-08-14
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v2
Enrollment increased: 188 → 500 participants
Trial arms changed: 4 → 6
Eligibility criteria+476 characters
[...] nfirmed unresectable locally advanced or metastatic melanoma and urinary tract tumors. Participants with unresectable locally advanced or metastatic melanoma or urinary tract tumors who have failed prior standard treatment or have no available standard treatment will be enrolled in Phase I and Phase IIa; those who have received or not received prior standard treatment will be enrolled in Phase IIa and Phase IIb. According to the response evaluation criteria for solid [...] he study and sign the informed consent. Exclusion Criteria: Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, t [...] [...]
Study sitescontacts updated at 1 of 1 site
Study title+25 characters
Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors
2026-01-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-18→confirmed 2025-12-17
Study sites0→1
2025-12-10
Original filing
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma and urinary tract tumors, 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.
Trial Details
NCT Number NCT07280832
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions Unresectable Locally Advanced or Metastatic Melanoma, Unresectable Locally Advanced or Metastatic Urinary Tract Tumors
Enrollment 500 participants
Start Date 2025-12-17
Primary Completion 2026-11-30 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-18