Status:
RECRUITING
Study of IBI363 in Patients with Advanced First-line Gastric Cancer
Lead Sponsor:
Xiangdong Cheng
Conditions:
IBI363 + Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced ...
Eligibility Criteria
Inclusion
- Male or female subjects, ≥ 18 years and ≤75 years.
- Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
- Subjects with at least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Expected survival time ≥ 3 months.
Exclusion
- Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
- Active uncontrolled bleeding or a known bleeding diathesis.
- Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06610799
Start Date
October 15 2024
End Date
December 31 2026
Last Update
November 20 2024
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000