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

Phase 1

Recruiting

• Conditions: IBI363 + Chemotherapy
• Interventions: Drug: IBI363

• Registration Number: NCT06610799
• Lead Sponsor: Xiangdong Cheng

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 or metastatic gastric and gastroesophageal junction adenocarcinoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Study Start: 2024-10-15
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	IBI363	IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Through out the study (up to 2 years)	The efficacy of solid tumors was evaluated according to RECIST v1.1
Disease control rate (DCR)	Through out the study (up to 2 years)	The efficacy of solid tumors was evaluated according to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival（PFS）;	Up to 2 years	The efficacy of solid tumors was evaluated according to RECIST v1.1
Overall Survival, OS）	Up to 2 years	The efficacy of solid tumors was evaluated according to RECIST v1.1
Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)	Up to 90 days after the last administration	Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China