A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

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

46 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator