A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.
About this trial
This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Sign the informed consent form voluntarily and follow the protocol requirements;
Gender is not limited;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
Disqualifiers
Chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have 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 fluorouracil or palliative radiotherapy within 2 weeks before the first dose; Chinese patent medicine within 2 weeks before the first administration;
History of severe cardiovascular and cerebrovascular diseases;
Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
active autoimmune and inflammatory diseases;
Trial design
Treatments tested in this trial
- BL-M05D1
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov