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New treatment option for Unresectable Locally Advanced or Metastatic Melanoma
Official title Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma
ClinicalTrials.gov ID: NCT07280832
What this study is testing
What is JMT108?
JMT108 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unresectable locally advanced or metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age≥18 years old.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma.
- Participants with unresectable locally advanced or metastatic melanoma who have failed prior standard treatment or have no available standard...
- According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one measurable lesion.
- ECOG PS of 0-1.
You likely can't join if
- Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other unapproved clinical trial drugs or...
- 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...
- Received systemic glucocorticoids or other immunosuppressive therapy within 14 days prior to the first use of the study drug. Exceptions include the...
- Known active central nervous system (CNS) metastases and/or leptomeningeal metastases. Patients with stable brain metastases who do not require local...
- Patients with active infections requiring intravenous anti-infective therapy within 14 days prior to the first administration.
See the full eligibility criteria
- Age≥18 years old.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma.
- 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...
- 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...
- Voluntarily agree to participate in the study and sign the informed consent.
- 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...
- 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...
- 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.
- Has a history of severe cardiovascular and cerebrovascular diseases.
- Has active or recurrent autoimmune diseases.
- 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...
- 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.
- Has a history of other malignant tumors within 5 years prior to the first administration or concurrent other malignant tumors.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.