Last updated: February 15, 2023
Sponsor: AskGene Pharma, Inc.
Overall Status: Active - Recruiting
Phase
1/2
Condition
Gastric Cancer
Stomach Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT05632939
ASK-LC-B589- Ib/II
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histopathologically confirmed unresectable locally advanced, recurrent, or metastaticadenocarcinoma of the gastric and gastroesophageal junction currently ineligible forsurgery and radical radiotherapy.
- Investigators determined that the present situation of the patient justifieschemotherapy plus immunotherapy as first-line treatment.
- Tumor tissue samples are CLDN18.2 positive detected by central laboratory
- ECOG performance status 0-1.
- The results of the laboratory tests must meet all criteria
- Life expectancy of at least 3 months.
Exclusion
Exclusion Criteria:
- Known active central nervous system metastasis or suspected cancerous meningitis;
- There are moderate to large amounts of abdominal and pleural fluid.
- The presence of clinically uncontrollable third interspace fluid;
- Patients with any other malignant tumors within the past 5 years.
- Applicable to anti-HER-2 drug therapy;
- Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past;
- Patients have received antitumor therapy during the first 4 weeks before study druguse;
- Pregnant or lactating women; or women of childbearing age who have a positive bloodpregnancy test during screening period; or women of childbearing age and their spouseswho are unwilling to take effective contraceptive measures during the period of thisclinical trial and within 6 months after the end of the clinical trial;
Study Design
Total Participants: 57
Study Start date:
February 10, 2023
Estimated Completion Date:
February 10, 2026
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100089
ChinaActive - Recruiting
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