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.
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.
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).
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.
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.
History of atopic constitution, asthma, or atopic dermatitis.
Single group
IBI363
DrugIBI363 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/VaccineBevacizumab 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
DrugNab-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.
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.
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.
Objective Response Rate (ORR) per RECIST v1.1
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Disease Control Rate (DCR) per RECIST v1.1
Disease control rate is defined as the proportion of patients with a best overall response of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by investigators.
Time to Response (TTR)
Time to response is defined as the time from first dose of study treatment to the date of first documented CR or PR according to RECIST v1.1.
Duration of Response (DoR)
Duration of response is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, according to RECIST v1.1.
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