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Recruiting NCT06610799

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

Phase I Interventional IBI363 + Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI363.
Who it may be relevant to
Registry conditions: IBI363 + Chemotherapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • Objective response rate (ORR) [Time frame: Through out the study (up to 2 years)]
  • Disease control rate (DCR) [Time frame: Through out the study (up to 2 years)]
Secondary outcome measures (3)
  • Progression Free Survival（PFS）; [Time frame: Up to 2 years]
  • Overall Survival, OS） [Time frame: Up to 2 years]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT06610799 · CIBI363Y110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗