This study is an open, multicenter, dose-escalation and expanded-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
Voluntarily sign the informed consent and follow the requirements of the protocol;
No gender limit;
Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
Expected survival time ≥3 months;
Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
History of severe heart disease;
QT prolongation, complete left bundle branch block, III degree atrioventricular block;
Active autoimmune and inflammatory diseases;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator