Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07449780

A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

A Randomized, Open-Label, Multicenter, Phase I/III Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
422 (estimated)
Sponsor
Akeso · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Conditions

Interventions

TypeNameDescription
DRUGAK104(SC)AK104:subcutaneous injection
DRUGAK104(IV)AK104:intravenous
DRUGCapecitabineoral
DRUGOxaliplatin injectionintravenous

Timeline

Start date
2026-03-31
Primary completion
2027-11-17
Completion
2028-02-15
First posted
2026-03-04
Last updated
2026-03-04

Source: ClinicalTrials.gov record NCT07449780. Inclusion in this directory is not an endorsement.