Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Recruiting
NCT Number: NCT06610799
Study of IBI363 in Patients with Advanced First-line Gastric Cancer
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
IBI363
DrugIBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W
Primary outcomes
-
Objective response rate (ORR)
Time frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
-
Disease control rate (DCR)
Time frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Secondary outcomes
-
Progression Free Survival（PFS）;
Time frame: Up to 2 years
The efficacy of solid tumors was evaluated according to RECIST v1.1
-
Overall Survival, OS）
Time frame: 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)
Time frame: Up to 90 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Xiangdong Cheng
Other
Registry information
Official study title
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
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Sep 24, 2024
- Registry last updated
- Nov 20, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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