A Study of BL-M08D1 in Patients With Locally Advanced or Metastatic Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.
About this trial
This study is an open, multicenter, dose-escalation and expansion-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M08D1 for injection in 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 (phase Ia); ≥18 years old (phase Ib);
Expected survival time ≥3 months;
Disqualifiers
Chemotherapy, biological therapy 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 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;
Trial design
Treatments tested in this trial
- BL-M08D1
Treatment groups
22 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