NCT06610799RecruitingPhase 1
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 · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 18 Sept 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Xiangdong Cheng
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06610799
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 15 Oct 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.