JMT108 injection for unresectable locally advanced or metastatic 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

This trial will try an experimental medicine called JMT108 to see if it is safe and helps adults with unresectable locally advanced or metastatic melanoma, especially those who have no standard treatment options left.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai JMT-Bio Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07280832 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase I/II study enrolls adults with unresectable locally advanced or metastatic melanoma to characterize safety, tolerability, pharmacokinetics, and preliminary efficacy of JMT108. Phase I uses a dose-escalation design to identify a recommended dose, followed by Phase IIa dose expansion and Phase IIb cohort expansion to further evaluate activity. Key eligibility includes histologic confirmation, at least one measurable lesion by RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Primary endpoints focus on safety and pharmacokinetics in early stages and on objective tumor responses in the expansion cohorts.

Who should consider this trial

Good fit: Adults aged 18 or older with histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma, at least one measurable lesion by RECIST 1.1, ECOG 0-1, expected survival ≥3 months, and adequate organ function are eligible, with Phase I/IIa focused on those who have failed or lack standard treatments and Phase IIb allowing broader enrollment.

Not a fit: Patients with resectable disease, ECOG performance status >1, life expectancy under three months, inadequate organ function, pregnant individuals, or children are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, JMT108 could become a new treatment option that shrinks tumors or prolongs disease control for patients with advanced melanoma who lack effective standard therapies.

How similar studies have performed: While other novel systemic therapies, including targeted agents and immunotherapies, have improved outcomes in advanced melanoma, JMT108 is investigational and published human efficacy data for this agent are not yet available.

Eligibility criteria

Inclusion Criteria:

1. Age≥18 years old.
2. Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma.
3. Participants with unresectable locally advanced or metastatic melanoma 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 IIb.
4. According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one measurable lesion.
5. ECOG PS of 0-1.
6. Expected survival ≥ 3 months.
7. Participants with adequate organ functions.
8. 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.
9. Voluntarily agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other unapproved clinical trial drugs or treatments within 4 weeks prior to the first administration of the study drug.
2. Prior use of IL-2/IL-15 cytokine therapy.
3. 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.
4. 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).
5. 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.
6. Patients with active infections requiring intravenous anti-infective therapy within 14 days prior to the first administration.
7. Has a history of severe cardiovascular and cerebrovascular diseases.
8. Has active or recurrent autoimmune diseases.
9. 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.
10. Has a history of arterial or venous thrombosis within 6 months prior to the first administration.
11. Has a history of serous effusions such as ascites or pleural effusion requiring drainage within 14 days prior to the first administration.
12. Has a history of other malignant tumors within 5 years prior to the first administration or concurrent other malignant tumors.

Where this trial is running

Beijing, Beijing Municipality

• BeiJing Cancer Hospital EC — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Information Group officer

Conditions Unresectable Locally Advanced or Metastatic Melanoma