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A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma
Sponsor: Akeso
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
294
Start Date
2024-09-10
Completion Date
2026-07
Last Updated
2024-09-19
Healthy Volunteers
No
Interventions
Drug: AK129 Drug:oxaliplatin Drug:capecitabine
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.
Drug: AK129 Drug:cadonilimab Drug:oxaliplatin Drug:capecitabine
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.
Locations (1)
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China