About this trial
This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.
Eligibility criteria
Qualifiers
Subject volunteered to participate in the study and signed an informed consent;
Male or female aged ≥18 years and ≤75 years;
Expected survival time ≥3 months;
ECOG score 0-1;
Disqualifiers
Prior treatment with an ADC drug with TOP I inhibitors as a toxin;
Before the first delivery within four weeks or five half-life used anti-tumor treatment; Palliative radiotherapy was given within 2 weeks before the first dose;
Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma;
Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
Trial design
Treatments tested in this trial
- BL-B01D1
- PD-1 monoclonal antibody
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator