Combination treatment for advanced gastric cancer
A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable Gastric/Esophagogastric Junction Cancer.
This study is testing a new combination treatment for people with advanced stomach cancer to see if it is safe and effective as a first-line option.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AskGene Pharma, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, Sintilimab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05632939 on ClinicalTrials.gov |
What this trial studies
This open-label, phase 1/2 study evaluates the safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 when combined with CAPOX and Sintilimab in patients with advanced, unresectable gastric and gastroesophageal junction adenocarcinoma. The study consists of two parts: a dose-escalation phase to determine the maximum tolerated dose and a subsequent expansion phase to assess efficacy. Participants will receive this combination as a first-line treatment option.
Who should consider this trial
Good fit: Ideal candidates include patients with unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who are ineligible for surgery.
Not a fit: Patients with active central nervous system metastasis or those with other malignancies within the past 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastric cancer who currently have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and immunotherapy in treating advanced gastric cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy. 2. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment. 3. Tumor tissue samples are CLDN18.2 positive detected by central laboratory 4. ECOG performance status 0-1. 5. The results of the laboratory tests must meet all criteria 6. Life expectancy of at least 3 months. Exclusion Criteria: 1. Known active central nervous system metastasis or suspected cancerous meningitis; 2. There are moderate to large amounts of abdominal and pleural fluid. 3. The presence of clinically uncontrollable third interspace fluid； 4. Patients with any other malignant tumors within the past 5 years. 5. Applicable to anti-HER-2 drug therapy； 6. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past； 7. Patients have received antitumor therapy during the first 4 weeks before study drug use; 8. Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;
Where this trial is running
Beijing, Beijing
- Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Dong Han
- Email: handong@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.