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.