A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-… (NCT06475300) | Clinical Trial Compass
RecruitingPhase 2
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
China570 participantsStarted 2024-06-25
Plain-language summary
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Sign the informed consent form voluntarily and follow the protocol requirements;
✓. Any gender;
✓. Age: ≥18 years old;
✓. Expected survival time for 3 months or more;
✓. Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;
✓. Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
✓. At least one measurable lesion meeting the RECIST v1.1 definition was required;
✓. ECOG 0 or 1;
Exclusion criteria
✕. Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;
✕. In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;
✕. Anti-tumor therapy such as chemotherapy or biological therapy has 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; Fluorouracil class oral drugs, etc.;