This is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies.
Life expectancy ≥12 weeks.
Eastern Cooperative Oncology Group performance status of 0-1.
Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors.
Agree to provide archived tumor tissue samples of primary or metastatic lesions.
Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.
Subjects who have uncontrollable or major cardiovascular disease refer to protocol.
Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.
Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.
Sequential
CM369
DrugSpecified dose on specified days.
Adverse events (AEs)
Serious Adverse events (SAEs)
Dose limiting toxicities (DLTs)
PK parameter: Peak Time (Tmax)
PK parameter: Half-life (t1/2)
PK parameter: Area Under the Curve (AUC)
PK parameters: Clearance (CL)
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