This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation/dose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
DP303c is an antibody conjugate drug (ADC), composed of one anti-HER2 monoclonal antibody coupled to one MMAE via an enzyme specific linker
A novel small molecule inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR2, KDR), and colony-stimulating factor 1 receptor (CSF-1R)
A chemotherapy
Paclitaxel or docetaxel or irinotecan is used as a control.
Dose-limiting toxicity(DLT) occurrence and incidence
Time frame: Up to approximately 36 months after the first participant is enrolled
Adverse events (AE) occurrence and incidence
Time frame: Up to approximately 36 months after the first participant is enrolled
Objective response rate (ORR) per RECIST 1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
Serious adverse events (SAE) occurrence and incidence
Time frame: Up to approximately 36 months after the first participant is enrolled
Disease control rate (DCR) per RECIST 1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
Overall survival(OS)
Time frame: Up to approximately 36 months after the first participant is enrolled
Blood drug concentration of DP303c
Time frame: Up to approximately 36 months after the first participant is enrolled
Blood concentration of total anti-DP303c antibody
Time frame: Up to approximately 36 months after the first participant is enrolled
Positive incidence of anti-DP303c antibody (ADA)
Time frame: Up to approximately 36 months after the first participant is enrolled
HER2 expression level
Time frame: Up to approximately 36 months after the first participant is enrolled
Blood concentration of simmitinib
Time frame: Up to approximately 36 months after the first participant is enrolled
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