A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 extensive-stage small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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;

• Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology;

• A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years;

• At least one measurable lesion meeting the RECIST v1.1 definition was required;

• No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;

• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;

⁃ For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Locations
Other Locations
China
Shanghai East Hospital
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2026-06
Participants
Target number of participants: 66
Treatments
Experimental: Study treatment
Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov