NCT06586294

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	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	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.

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China