About this trial
This study is an open-label, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of Lutetium \[177Lu\] BL-ARC001 in patients with locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
Gender: no restriction;
Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
Expected survival time ≥3 months;
Disqualifiers
Use of chemotherapy, biotherapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose;
History of severe heart disease;
QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
Active autoimmune or inflammatory diseases;
Trial design
Treatments tested in this trial
- Lutetium [177Lu] BL-ARC001
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator