ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma

A Phase III Study Evaluating the Efficacy and Safety of ASKB589 Combined With CAPOX and PD-1 Inhibitor as First-Line Treatment in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).

This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).

This study will also evaluate efficacy, physical function, safety, and tolerability of ASKB589, as well as its effects on quality of life. Pharmacokinetics (PK) of ASKB589 and the immunogenicity profile of ASKB589 will be evaluated as well.

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction
2. Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to randomization
3. Suitable for chemotherapy combined with PD-1 inhibitor
4. Not suitable for anti-HER2 therapy
5. Have at least one measurable lesion according to RECIST1.1 assessed by site investigator within 28 days prior to randomization
6. CLDN 18.2 positive

Exclusion Criteria:

1. Patients with active central nervous system (CNS) metastases or suspected carcinomatous meningitis
2. Participants have significant gastric bleeding
3. The presence of clinically uncontrollable third interspace fluid
4. Received anti-CLDN18.2 antibody at any time in the past
5. Suspected complete or partial obstruction of gastroesophageal access