RecruitingPhase 2NCT06437509

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

66 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of BL-B01D1 (a new antibody-drug conjugate that delivers chemotherapy directly to cancer cells) plus a PD-1 immunotherapy drug as a first-line treatment for extensive-stage small cell lung cancer — an aggressive form of lung cancer that has spread widely. **You may be eligible if...** - You are between 18 and 75 years old - You have newly diagnosed extensive-stage small cell lung cancer confirmed by biopsy or cell testing - You have not previously received treatment for this cancer - You have at least one measurable tumor - Your expected survival is at least 3 months - You are in good general health (ECOG score 0–1) - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have previously received a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) therapy - Your cancer has non-small cell components mixed in - You have active autoimmune diseases or are on long-term steroids - You have serious heart, brain, or cardiovascular disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGPD-1 monoclonal antibody

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT06437509


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