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

AskGene Pharma

Status and phase: Enrolling; Phase 3

Conditions: Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Drug: Capecitabine; Drug: ASKB589; Drug: Oxaliplatin; Drug: Tislelizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06206733

ASK-LC-B589-III-1

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 780 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

780 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

Treatment with intravenous infusion of ASKB589 on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria of treatment discontinuation.

Treatment:

Drug: Capecitabine

Drug: ASKB589

Drug: Tislelizumab

Drug: Oxaliplatin

Group B

Placebo Comparator group

Description:

Treatment with intravenous infusion of placebo on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria for treatment discontinuation.

Treatment:

Drug: Capecitabine

Drug: Tislelizumab

Drug: Placebo

Drug: Oxaliplatin