Study of IBI363 in Patients with Advanced First-line Gastric Cancer

Recruiting now · Phase 1

Conditions studied: IBI363 + Chemotherapy

In brief

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.

Key facts

Study ID

NCT06610799

Run by

Xiangdong Cheng

People needed

40

Starts

2024-10-15

Expected to finish

2026-12-31

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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