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

Prior treatment

• 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).
• Patients with active infections requiring intravenous anti-infective therapy within 14 days prior to the first administration.
• Has a known history of receiving immunotherapy with the occurrence of grade ≥3 immune-related adverse events (irAEs) (excluding immune-related endocrine abnormalities that have been stabilized) or grade ≥2 immune-related myocarditis.
• Has a history of arterial or venous thrombosis within 6 months prior to the first administration.
• Has a history of serous effusions such as ascites or pleural effusion requiring drainage within 14 days prior to the first administration.

Other illness

• Has a history of severe cardiovascular and cerebrovascular diseases.
• Has active or recurrent autoimmune diseases.
• Has a history of other malignant tumors within 5 years prior to the first administration or concurrent other malignant tumors.

Other

• 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.

• 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.
• Participants with adequate organ functions.
• Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 6 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.
• Voluntarily agree to participate in the study and sign the informed consent.