NCT07361991

IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer

A Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Bevacizumab With or Without Nab-Paclitaxel as Second-Line Therapy in Patients With Advanced Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is for patients with advanced or metastatic gastric cancer whose disease has worsened after first-line systemic therapy. IBI363 is an investigational antibody that may help the immune system recognize and attack cancer cells. This trial will evaluate IBI363 in combination with bevacizumab, with or without nab-paclitaxel, as a second-line treatment. The study has two parts. In the phase Ib part, small groups of patients will receive IBI363 plus bevacizumab with or without nab-paclitaxel to evaluate the safety, side effects, and tolerability of the combination and to determine an appropriate dose for further study. In the phase II part, additional patients will receive the selected regimen to assess the preliminary antitumor activity of IBI363 in combination with bevacizumab ± nab-paclitaxel, including tumor response and other clinical outcomes, as well as to further describe the safety profile. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons defined in the protocol.

Conditions

• Advan'ce'd
• Advanced

Interventions

Type	Name	Description
DRUG	IBI363	IBI363 will be administered as an intravenous infusion at 1.5 mg/kg or 3 mg/kg every 3 weeks (Q3W) in 28-day cycle 1 and 21-day subsequent cycles, in combination with bevacizumab with or without nab-paclitaxel, as second-line therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
BIOLOGICAL	Bevacizumab	Bevacizumab 7.5 mg/kg will be administered as an intravenous infusion every 3 weeks (Q3W) in combination with IBI363, with or without nab-paclitaxel, and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined reasons.
DRUG	Nab-paclitaxel	Nab-paclitaxel 260 mg/m² will be administered as an intravenous infusion every 3 weeks (Q3W) for up to 4 cycles in combination with IBI363 and bevacizumab in patients in Cohort 2.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: China