NCT07280832
Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors
Recruiting · Phase 1, Phase 2 · Shanghai JMT-Bio Inc. · registry updated 2026-08-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Age≥18 years old.
- Histologically or cytologically confirmed 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; 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 tumors (RECIST 1.1), having at least one measurable lesion.
- ECOG PS of 0-1.
- Expected survival ≥ 3 months.
Exclusion
- Within 4 weeks prior to the first administration of the investigational drug, the patient had received chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy (excluding small-molecule targeted drugs), immunotherapy, or other unmarketed investigational drugs or treatments; for small-molecule targeted drugs, use was within 2 weeks prior to the first administration of the investigational drug or within 5 half-lives of the drug (whichever is longer, not exceeding 4 weeks); and antitumor-indicated traditional Chinese medicine/products were used within 2 weeks prior to the first administration of the investigational drug.
- Prior use of IL-2/IL-15 cytokine therapy.
- Received major organ surgery (excluding needle biopsy) or experienced severe trauma within 4 weeks prior to the first administration of the study drug, or requires elective surgery during the study period.
- Received systemic glucocorticoids or other immunosuppressive therapy within 14 days prior to the first use of the study drug. Exceptions include the following situations: receiving physiological replacement doses of hydrocortisone or other equivalent doses of hormonal therapy (i.e., prednisone ≤ 10 mg/day or other equivalent doses of hormones); receiving topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoid therapy; receiving short-course glucocorticoids for preventive treatment (e.g., prevention of contrast agent allergy).
- Known active central nervous system (CNS) metastases and/or leptomeningeal metastases. Patients with stable brain metastases who do not require local treatment for brain metastases are eligible for inclusion.
- Patients with active infections requiring intravenous anti-infective therapy within 14 days prior to the first administration.