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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •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.
Arms & Interventions
Cohort 1
IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma
Intervention: IBI363 (Drug)
Outcomes
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）;(Up to 2 years)
- Overall Survival, OS）(Up to 2 years)
- 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)
Investigators
Xiangdong Cheng
Secretary of the party committee
Zhejiang Cancer Hospital