This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate
AK112 Injection is a PD-1/VEGF bispecific antibody
Fudan University Shanghai Cancer Center
Shanghai, China
Number of participants with dose limiting toxicities(DLTs)
DLTs are defined as toxicities that meet predefined severity criteria, and assessed as having a suspected relationship to study drug
Time frame: During the first 3 weeks of treatment
Objective Response Rate(ORR)
ORR is the proportion of participants with complete response(CR) or partial response(PR)
Time frame: Up to 2 years
Number of participants with adverse events (AEs)
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
Time frame: From the time of informed consent signed through 90 days after the last dose
Progression Free Survival(PFS)
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
Disease Control Rate(DCR)
DCR is defined as the proportion of participants with CR, PR, or SD
Time frame: Up to 2 years
Duration of response(DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Time to response(TTR)
TTR is defined as the time to objective response
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Time frame: Up to 2 years
Overall survival(OS)
OS is defined as the time from the first dose to death from any cause.
Time frame: Up to 2 years