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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Specified dose on specified days.
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGJilin Cancer Hospital
Changchun, Jilin, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGAdverse events (AEs)
Time frame: 90 weeks
Serious Adverse events (SAEs)
Time frame: 90 weeks
Dose limiting toxicities (DLTs)
Time frame: 90 weeks
PK parameter: Peak Time (Tmax)
Time frame: 90 weeks
PK parameter: Half-life (t1/2)
Time frame: 90 weeks
PK parameter: Area Under the Curve (AUC)
Time frame: 90 weeks
PK parameters: Clearance (CL)
Time frame: 90 weeks
PK parameter: Apparent volume of distribution of steady state (Vss)
Time frame: 90 weeks
Immunogenicity: Incidence of anti-CM369 antibody
Time frame: 90 weeks
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