Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in China / NCT06610799
Recruiting Phase 1

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

NCT06610799 · tracked via the Priya Life Science China tracker
Sponsor
Xiangdong Cheng
Phase
Phase 1
Started
2024-10-15
Last updated
2024-11-20

Condition(s) studied

IBI363 + Chemotherapy

Investigational drug(s) / intervention(s)

IBI363 →

IBI363: IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

More Xiangdong Cheng trials in China

A Pan-cancer Screening and Diagnosis Model Based on Abdominal CT Was Established Recruiting
Perioperative Tislelizumab Plus Chemotherapy Versus Chemotherapy Alone in MHC-II-Positive Gastric/GEJ Cancer Starting soon
QL1706 Combined With SOX Used in Theperioperative Treatment Recruiting
Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment. Starting soon

Other trials for the same condition

Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06610799 on ClinicalTrials.gov ↗ ← All trials in China