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

NCT07361991 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI363GC002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Advanced

Outcome Measures

Primary Outcomes (2)

• Incidence and Severity of Adverse Events

  Incidence, severity, and relationship to study treatment of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs), graded according to NCI CTCAE. Changes from baseline in 12-lead electrocardiogram (ECG), vital signs, physical examination findings, and clinical laboratory test results will also be assessed.

  From first dose of study treatment until 90 days after the last dose or end of study, whichever occurs first.

• Overall Survival (OS)

  Overall Survival (OS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of death.

  12 months after the last subject participating in

Secondary Outcomes (5)

• Objective Response Rate (ORR) per RECIST v1.1

  6 months after the last subject participating in

• Disease Control Rate (DCR) per RECIST v1.1

  12 months after the last subject participating in

• Time to Response (TTR)

  12 months after the last subject participating in

• Duration of Response (DoR)

  12 months after the last subject participating in

• Progression-Free Survival (PFS)

  12 months after the last subject participating in

Study Arms (1)

IBI363 + Bevacizumab± nab-paclitaxel

EXPERIMENTAL

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

Drug: IBI363; Biological: Bevacizumab; Drug: Nab-paclitaxel

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.

IBI363 + Bevacizumab± nab-paclitaxel

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.

IBI363 + Bevacizumab± nab-paclitaxel

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.

IBI363 + Bevacizumab± nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent: The patient must voluntarily sign a written informed consent form and be able to comply with the visit schedule and procedures specified in the protocol.
• Age: 18 to 75 years (inclusive), male or female.
• Diagnosis and prior therapy:
• \* Histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma (GC or GEJC).
• Disease progression or intolerance after prior first-line systemic antitumor therapy including immunotherapy.
• Primary immune resistance: best response during immunotherapy is stable disease (SD) lasting \< 12 weeks, or progressive disease (PD).
• Acquired immune resistance:
• \. For patients with PD on immunotherapy: best response during treatment is complete response (CR), partial response (PR), or SD lasting ≥ 12 weeks; 2. For patients who discontinued immunotherapy for reasons other than disease progression and subsequently developed PD: best response during treatment is CR, PR, or SD lasting ≥ 12 weeks, and the interval between last immunotherapy dose and PD is ≤ 6 months.
• \. Baseline hematology (within 7 days before first dose of study drug) must meet all of the following:
• Hemoglobin ≥ 90 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
• Platelet count ≥ 100 × 10⁹/L;
• Eosinophils \< 1.5 × upper limit of normal (ULN).
• \*In this protocol, "baseline" is defined as the last available assessment prior to the first dose of study drug. Within 7 days before blood sampling, patients must not receive blood products (including packed red blood cells, apheresis platelets, cryoprecipitate, etc.), erythropoiesis-stimulating agents, or colony-stimulating factor support.\*
• \. Baseline serum chemistry (within 7 days before first dose) must meet all of the following:

You may not qualify if:

• Pregnant or breastfeeding women, or women planning to become pregnant before the first dose of study drug, during study treatment, or within 6 months after the last dose.
• History of active thrombosis, deep venous thrombosis, or pulmonary embolism within 4 weeks before the first dose of study drug, unless adequately treated and considered clinically stable by the investigator.
• Clinically significant cardiovascular or cerebrovascular disease, including but not limited to:
• \* Ventricular arrhythmias or other uncontrolled arrhythmias requiring medical intervention (e.g., anti-arrhythmic therapy);
• \* Severe conduction abnormalities (e.g., third-degree atrioventricular block);
• \* QT interval corrected by Fridericia (QTcF) ≥ 480 ms;
• \* Uncontrolled arterial hypertension despite optimal medical therapy (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
• \* History of myocarditis;
• \* Current congestive heart failure requiring treatment;
• \* Left ventricular ejection fraction (LVEF) \< 50%;
• \* New York Heart Association (NYHA) class III or IV heart failure;
• \* Acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent implantation within 6 months prior to the first dose;
• \* Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose;
• \* Known active seizure disorders.
• Interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, or other forms of restrictive lung disease that require corticosteroids or other treatment, or a history of severely impaired pulmonary function.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

Bevacizumab; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yongxu Jia

CONTACT

0086-15237128281; fccjiayx@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)