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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Intravenous (IV) administration
BeiJing Cancer Hospital EC
Beijing, Beijing Municipality, China
RECRUITINGDose-Limiting Toxicity (DLT) (Phase I)
To evaluate the safery of JMT108 in subjects.
Time frame: Approximately 28 days.
Adverse Events (AEs) (Phase I)
To evaluate the safery of JMT108 in subjects.
Time frame: Through study completion, an average of 1 year
Overall Response Rate (ORR) (Phase II)
Through study completion, an average of 1 year.
Time frame: To evaluate the efficacy of JMT108 in subjects.
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of JMT108 in subjects.
Time frame: Through study completion, an average of 1 year.
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