Study of IBI363 in Patients with Advanced First-line Gastric Cancer
Phase Ib Study 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
Xiangdong Cheng
40 participants
Oct 15, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- 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.
Interventions
IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06610799