This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 with or without Chemotheray in Patients With Advanced Solid Tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence and severity of adverse events (AEs)
AEs are assessed based on NCI CTCAE v6.0.
Time frame: Up to approximately 2 years
Maximum tolerate dose(MTD)
MTD of 7MW3711
Time frame: Up to approximately 2 years
Recommended Expansion Dose (RED)
RED of 7MW3711
Time frame: Up to approximately 2 years
Area Under the Concentration-time Curve (AUC)
AUC of 7MW3711
Time frame: Up to approximately 2 years
Maximum concentration (Cmax)
Cmax of 7MW3711
Time frame: Up to approximately 2 years
Plasma clearance (CL)
CL of 7MW3711
Time frame: Up to approximately 2 years
Half-life (t1/2)
t1/2 of 7MW3711
Time frame: Up to approximately 2 years
Time to peak drug concentration (Tmax)
Tmax of 7MW3711
Time frame: Up to approximately 2 years
Investigator-assessed progression-free survival (PFS)
PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Carboplatin will be administered as IV infusion.
Time frame: Up to approximately 2 years
Overall survival (OS)
OS defined as the time interval from the first study drug administration to death due to any cause.
Time frame: Up to approximately 2 years
Investigator-assessed disease control rate (DCR)
DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
Time frame: Up to approximately 2 years
Immunogenicity
Incidence and rates of ADA
Time frame: Up to approximately 2 years