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Trial Title:
Study of IBI363 in Patients With Advanced First-line Gastric Cancer
NCT ID:
NCT06610799
Condition:
IBI363 + Chemotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI363
Description:
IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W
Arm group label:
Cohort 1
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 or metastatic gastric and gastroesophageal junction
adenocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female subjects, ≥ 18 years and ≤75 years.
2. Subjects with unresectable advanced or metastatic gastric and gastroesophageal
junction adenocarcinoma without prior systematic treatment.
3. Subjects with at least one measurable lesion according to RECIST v1.1.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
5. Expected survival time ≥ 3 months.
Exclusion Criteria:
1. Women who are pregnant or lactating, or intending to become pregnant before, during,
or within 6 months after the last dose of study drug.
2. Active uncontrolled bleeding or a known bleeding diathesis.
3. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Xiangdong Cheng
Phone:
13968032995
Email:
chengxd516@126.com
Start date:
September 30, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Xiangdong Cheng
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06610799
