The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors.
This is a dose escalation and expansion study with the aim to evaluate and characterize the tolerability and safety profile of CSPCHA131 alone (Stage I) or plus chemotherapy (Stage II) in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGMaximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
Time frame: Time Frame: 28 days
Incidence of adverse events (AEs) and serious adverse events throughout the trial;
Time frame: from enrollment to the end of the trial (2 years)
Objective response rate (ORR) defined by RECIST Criteria Version 1.1;
ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR).
Time frame: from enrollment to the end of the trial (2 years)
Progression free survival (PFS) defined by RECIST Criteria Version 1.1;
PFS is defined as the time from the start of treatment until disease progression or death from any cause, whichever is earlier.
Time frame: from enrollment to the end of the trial (2 years)
AUC0-t
PK parameter: AUC0-t
Time frame: 28 days
AUC0-∞
PK parameter: AUC0-∞
Time frame: 28 days
Cmax
PK parameter: Cmax
Time frame: 28 days
Css_max
PK parameter: Css\_max
Time frame: 28 days
Css_min
PK parameter: Css\_min
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 28 days
DF
PK parameter: DF
Time frame: 28 days
Ke
PK parameter: Ke
Time frame: 28 days
Tmax
PK parameter: Tmax
Time frame: 28 days
Vz
PK parameter: Vz
Time frame: 28 days
T1/2
PK parameter: T1/2
Time frame: 28 days
CL
PK parameter: CL
Time frame: 28 days