This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.
Fully informed of the study, with good compliance and willing to provide written informed consent.
Male or female participants aged ≥18 years (at the time of obtaining informed consent).
Participants with histologically or cytologically confirmed advanced malignant tumors who are unresponsive or intolerant to all standard of care, or have no standard of care available. For locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC without sensitive gene mutations, participants who have not received systemic treatment in the advanced stage and are unwilling to accept the current standard treatment can also be enrolled in the cohort expansion phase.
Participants with at least one evaluable tumor lesion in the Phase 1a dose-escalation phase; and at least one measurable lesion in the Phase 1a dose-expansion phase and Phase 1b (tumor lesions in the past radiation fields or that underwent locoregional therapy are generally not considered measurable lesions unless the lesion shows definite progression or persists three months after radiotherapy) according to RECIST v1.1.
Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).
Major surgery (excluding biopsy) or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug, or plan to do major surgery during the study period.
Systemic corticosteroids or other immunosuppression therapy within 14 days prior to the first dose of the investigational drug. Except for the following situations: use of physiological replacement doses of hydrocortisone or other equivalent doses of hormones (i.e., prednisone ≤10 mg/day or other equivalent doses of hormones); use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid therapy; use of short-course glucocorticoids for prophylaxis (e.g., prevention of contrast allergy).
Live vaccines within 4 weeks prior to the first dose of investigational drug. Note: Seasonal influenza vaccines are inactivated vaccines in a broad sense and are allowed. Intranasal influenza vaccines are live vaccines and are not permitted.
Single group
JMT108
DrugIntravenous (IV) administration every three weeks (D1) in a 3-week cycle.
Pembrolizumab
DrugIntravenous (IV) administration every three weeks (D1) in a 3-week cycle.
Ivonescimab
DrugIntravenous (IV) administration every three weeks (D1) in a 3-week cycle.
Dose-Limiting Toxicity(DLT)
To evaluate the safery of JMT108 in subjects.
Adverse Events (AEs)
To evaluate the safery of JMT108 in subjects
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of JMT108 in subjects.
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