This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate
Scientia Clinical Research
Sydney, New South Wales, Australia
RECRUITINGNumber of participants with dose limiting toxicities (DLTs)
DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Time frame: During the first 3 weeks of treatment.
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 of study drug
Serum PK concentration of AK146D1
Serum PK concentration of AK146D1 in participants after administration
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
Anti-drug antibodies (ADA)
The number and percentage of participants with detectable anti-drug antibodies (ADA)
Time frame: From pre-dose to 90 days post end of treatment
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) assessed per RECIST v1.1
DCR is defined as the proportion of participants with CR, PR, or SD, assessed based on RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
TTR is defined as the time to objective response based on RECIST v1.1.
Time frame: Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is defined as the time from the first dose to death from any cause.
Time frame: Up to approximately 2 years