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.
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.
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).
Sequential
JMT108
DrugIntravenous (IV) administration
6
Treatment groupsSee each treatment group below.
Dose-Limiting Toxicity (DLT) (Phase I)
To evaluate the safery of JMT108 in subjects.
Adverse Events (AEs) (Phase I)
To evaluate the safery of JMT108 in subjects.
Overall Response Rate (ORR) (Phase II)
Through study completion, an average of 1 year.
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of JMT108 in subjects.
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