This is a phase II clinical study evaluating the safety, tolerability, pharmacokinetics and antitumor efficacy of AK146D1 in combination with AK112 or other anticancer therapies in patients with advanced Non-Small Cell Lung Cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
348
AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate.
AK112 is a PD-1/VEGF bispecific antibody.
Carboplatin or cisplatin will be administered.
SunYat-sen University Cancer Center
Guangzhou, Guangdong, China
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 in Safety Run-in Phase.
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 signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.
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.
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.
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
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.
Li Zhang, Study Principal Investigator
CONTACT
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Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
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.
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.
Serum PK concentration of AK146D1 and AK112
Serum PK concentration of AK146D1 and AK112 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 30 days post end of treatment.