NCT06206733Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 780 (estimated)
- First submitted
- 12 Dec 2023
- Start date
- 25 Jan 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- AskGene Pharma, Inc.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06206733
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 780
- From 25 Jan 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received anti-CLDN18.2 antibody at any time in the past
Other illness
- Participants have significant gastric bleeding
Other
- Patients with active central nervous system (CNS) metastases or suspected carcinomatous meningitis
- The presence of clinically uncontrollable third interspace fluid
- Suspected complete or partial obstruction of gastroesophageal access
Who the study is looking for
- Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction
- Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to randomization
- Suitable for chemotherapy combined with PD-1 inhibitor
- Not suitable for anti-HER2 therapy
- Have at least one measurable lesion according to RECIST1.1 assessed by site investigator within 28 days prior to randomization
- CLDN 18.2 positive
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.