Clinical trial · Interventional
Study of IBI363 in Patients with Advanced First-line Gastric Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IBI363 + Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI363 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma
- interventionNames
- Drug: IBI363
Primary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- Through out the study (up to 2 years)
- description
- The efficacy of solid tumors was evaluated according to RECIST v1.1
- measure
- Disease control rate (DCR)
- timeFrame
- Through out the study (up to 2 years)
- description
- The efficacy of solid tumors was evaluated according to RECIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available