Evaluating IBI363 with chemotherapy for advanced gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yanxi Pu
• Email: yanxi.pu@innoventbio.com
• Phone: 18523197816

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Perioperative IBI363 plus chemotherapy for MHC-II–negative locally advanced gastric and gastroesophageal junction adenocarcinoma

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• Anti-PD-1 with chemotherapy and intraperitoneal nab-paclitaxel for untreated advanced gastric cancer with ascites

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• Immunotherapy Plus Carbon Ion Radiotherapy for Locally Advanced Cervical Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.