About this trial
This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-ARC002 Injection in patients with locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
No gender restriction;
Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
Expected survival ≥3 months;
Disqualifiers
Use of chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;
History of severe cardiac disease;
QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
Active autoimmune diseases and inflammatory diseases;
Trial design
Treatments tested in this trial
- BL-ARC002
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator