Combination treatment for advanced gastric cancer
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 testing a new combination treatment for advanced stomach cancer to see if it helps patients live longer without their disease getting worse compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 780 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AskGene Pharma, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06206733 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind phase III clinical study aims to evaluate the efficacy of ASKB589 in combination with CAPOX and a PD-1 inhibitor compared to a placebo with the same chemotherapy regimen in patients with advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. The primary endpoint is Progression Free Survival (PFS), and the study will also assess safety, tolerability, physical function, quality of life, and pharmacokinetics of ASKB589. Conducted in China, this study seeks to provide a new first-line treatment option for eligible patients.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who are CLDN 18.2 positive and suitable for chemotherapy with a PD-1 inhibitor.
Not a fit: Patients with active central nervous system metastases, significant gastric bleeding, or those who have previously received anti-CLDN18.2 therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve progression-free survival for patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Beijing cancer hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yuan Yangzhou
- Email: yuanyangzhou@ask-pharm.com
- Phone: 025-8509062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.