Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
AK129 is administered intravenously according to the frequency every three weeks(Q3W) and different dosage of administration at different stages.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.
AK129 is administered intravenously according to the frequency Q3W and different dosage of administration at different stages. Cadonilimab is administered intravenously according to the frequency and dosage 10mg/kg Q3W.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China
Incidence and severity of adverse events(AE)
Incidence and severity of AEs is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab
Time frame: Up to approximately 2 years
Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR)
Incidence of SAE and SUSAR is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab
Time frame: Up to approximately 2 years
Incidence of dose-limiting toxicity(DLT)
The purpose of DLT is to find the Phase II recommended dose(RP2D) or Maximum Tolerated Dose(MTD)
Time frame: Up to approximately 2 years
Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension
Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab
Time frame: Up to approximately 2 years
Objective Solution Rate (ORR) based on RECIST v1.1
The purpose of ORR is aim to evaluate the antitumor effect,and ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1.
Time frame: Up to approximately 2 years
Disease control rate(DCR)
Disease control rate(DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR or PR or stable disease(SD) per RECIST v1.1.
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Time frame: Up to approximately 2 years
duration of response(DoR)
Duration of response(DoR) is defined as the period from the first documentation of confirmed response(CR or PR) to the first documentation of progressive disease(PD) as per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
time to response(TTR)
Time to response(TTR) is defined as the time from the first dose of investigational products until the first confirmation of CR or PR.
Time frame: Up to approximately 2 years
progression-free survival(PFS)
Progression-free survival(PFS) is defined as the time from the first dose of investigational products until documentation of progressive disease(PD) as per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
overall survival(OS)
Overall survival(OS) is defined as the time from the first dose of investigational products until death due to any cause.
Time frame: Up to approximately 2 years
Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument
Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument to evaluate the Pharmacokinetics(PK).
Time frame: Up to approximately 2 years
Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab
Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Time frame: Up to approximately 2 years