Evaluating IBI363 with chemotherapy for advanced 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
This study is testing a new treatment combining IBI363 with chemotherapy for people with advanced stomach cancer to see if it helps them better than current options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06610799 on ClinicalTrials.gov |
What this trial studies
This phase 1b study aims to assess the safety, tolerability, and efficacy of IBI363 when combined with oxaliplatin and capecitabine (XELOX) for patients with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. The study will enroll male and female participants aged 18 to 75 who have not received prior systemic treatment and have measurable lesions. The primary focus is to determine how well this combination therapy works as a first-line treatment option.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unresectable advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have not undergone prior systemic treatment.
Not a fit: Patients with active bleeding disorders, brain metastases, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastric cancer.
How similar studies have performed: While this specific combination is being evaluated for the first time, similar approaches in treating gastric cancer have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yanxi Pu
- Email: yanxi.pu@innoventbio.com
- Phone: 18523197816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.