Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant 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

Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma (NCT07280832) is a Phase 1 / Phase 2 interventional studying Unresectable Locally Advanced or Metastatic Melanoma, sponsored by Shanghai JMT-Bio Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma, 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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Unresectable Locally Advanced or Metastatic Melanoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 188 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Unresectable Locally Advanced or Metastatic Melanoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age≥18 years old. 2. diagnosed by tissue sample (biopsy-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 your organs (liver, kidneys, etc.) are working well enough based on blood testss. 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

JMT108

Intravenous (IV) administration

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

BeiJing Cancer Hospital EC

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07280832), the sponsor (Shanghai JMT-Bio Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07280832 clinical trial studying?

Who can participate in NCT07280832?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07280832?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07280832. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07280832. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.