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
Overview
- Phase
- Phase 2
- Intervention
- BL-B01D1
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;
- •Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;
- •Pathology suggested small cell carcinoma containing non-small cell carcinoma components;
- •Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ;
- •Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ;
- •QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ;
- •Active autoimmune diseases and inflammatory diseases ;
- •Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose;
- •Other malignancies that have progressed or require treatment within 5 years prior to the first dose;
- •Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening;
Arms & Interventions
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.
Intervention: BL-B01D1
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.
Intervention: PD-1 monoclonal antibody
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Up to approximately 24 months
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Recommended Phase II Dose (RP2D)
Time Frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
Secondary Outcomes
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)