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

Conditions

• Advan'ce'd
• Advanced

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• IBI363 — DRUG
  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.
• Bevacizumab — BIOLOGICAL
  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.
• Nab-paclitaxel — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jan 23, 2026

Start date

Mar 31, 2026

Status verified

Jan 2026

Primary completion

Sep 30, 2028

Completion

Sep 30, 2030

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: IBI363 + Bevacizumab± nab-paclitaxel
  Phase Ib Patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC or GEJC) who have failed prior standard first-line therapy will receive the following treatments: IBI363 in combination with bevacizumab± nab-paclitaxel. IBI363 will be administered at a dose of 3 mg/kg Q3W in Cycle 1, followed by a maintenance dose of 1.5 mg/kg Q3W. Bevacizumab will be administered at 7.5 mg/kg Q3W. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. Nab-paclitaxel will be administered at 260 mg/m² Q3W for 4 cycles. During the Phase Ib safety lead-in period, patients will be observed for one treatment

Primary Outcome Measure

Incidence and Severity of Adverse Events [ Time Frame: From first dose of study treatment until 90 days after the last dose or end of study, whichever occurs first. ]

Central Contacts

• Yongxu Jia
  0086-15237128281
  [email protected]