Zhejiang Cancer Hospital
Hanzhou, Zhejiang, 310005, China
NCT Number: NCT06586294
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
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Hanzhou, Zhejiang, 310005, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to approximately 2 years
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 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
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 is aim to evaluate the safety of AK129 combined with chemotherapy with or without cadonilimab
Time frame: Up to approximately 2 years
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) 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.
Time frame: Up to approximately 2 years
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) 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) 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) 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 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 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Contact information is provided by the study sponsor or research team.
Akeso
Industry
A Phase Ib/II Open Label,Dose Escalation and Dose Extension Study Evaluating the Safety, Tolerability, and Initial Antitumor Efficacy of Anti-PD-1 and Lymphocyte Activation Gene 3(LAG-3) Bispecific Antibody AK129 Combined With Chemotherapy With or Without Cadonilimab in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Negative Unresectable Locally Advanced or Metastatic G/GEJ Adenocarcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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