Status:
UNKNOWN
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD...
Eligibility Criteria
Inclusion
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- Age ≥ 18 years and ≤ 75 years when ICF is signed;
- Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
- Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);
- Measurable lesion according to RECIST v1.1 by IRRC;
- ECOG score 0-1;
- Expected survival 12 weeks.
Exclusion
- Has other active malignancies within 5 years before the first administration of the study drug;
- Plan to or have previously received organ or bone marrow transplantation;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;
- Have received any research drugs within 14 days before the first use of the study drugs.
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05246982
Start Date
March 23 2022
End Date
March 30 2024
Last Update
May 2 2022
Active Locations (2)
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1
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, China, 730000
2
Fudan University shanghai cancer center
Shanghai, China, 200000