This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39G with or without standard therapy in adult patients with advanced malignant solid tumors. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
SCTB41 plus SCTB39G of different doses, IV, every 3 weeks
Dose-Limiting Toxicity(DLT)
Incidence of dose-limiting toxicities up to the Day 21 visit
Time frame: From Day 0 up to Day 21
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Time frame: Up to 2 years
Frequency of adverse events (AEs)
To investigate the safety characteristics.
Time frame: Up to 2 years
Disease Control Rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.
Time frame: Up to 2 years
Progression-Free Survival (PFS)
The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Overall Survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
Time frame: Up to 2 years
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