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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Dose Escalation Stage | Experimental | JMT108 intravenous (IV) administration, use as specified in the clinical study protocol. |
|
| Phase IIa: Dose Expansion Stage | Experimental | The administered dose of JMT108 selected by the SMC. |
|
| Phase IIb: Cohort 1 | Experimental | RP2D of JMT108 selected by the SMC. |
|
| Phase IIb: Cohort 2 | Experimental | RP2D of JMT108 selected by the SMC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT108 | Drug | Intravenous (IV) administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) (Phase I) | To evaluate the safery of JMT108 in subjects. | Approximately 28 days. |
| Adverse Events (AEs) (Phase I) | To evaluate the safery of JMT108 in subjects. | Through study completion, an average of 1 year |
| Overall Response Rate (ORR) (Phase II) | Through study completion, an average of 1 year. | To evaluate the efficacy of JMT108 in subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To evaluate the systemic pharmacokinetics of JMT108 in subjects. | Through study completion, an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeiJing Cancer Hospital EC | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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This is an open-label, multicenter Phase I/II clinical study
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This is an open-label, multicenter Phase I/II clinical study
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |