RecruitingPhase 2NCT05924841

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Extensive Stage Small Cell Lung Cancer (SCLC)


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

100 participants

Start Date

Nov 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II study is designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 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 is testing new treatment options for people with extensive-stage small cell lung cancer (ES-SCLC) — a fast-growing type of lung cancer that has spread beyond the chest. The trial tests three separate approaches: a drug called BL-B01D1 alone, a drug called SI-B003 alone, and the combination of both. Different groups are enrolled based on how many prior treatments they have received. **You may be eligible if:** - You are 18–75 years old in good physical health (ECOG 0–1) - You have been diagnosed with extensive-stage small cell lung cancer confirmed by biopsy - Depending on which group applies to you: you have failed 3 or more prior treatment lines, OR failed or could not tolerate standard first-line therapy, OR you have not received any prior systemic therapy for this cancer - You have at least one measurable tumor on imaging - Your expected survival is at least 3 months **You may NOT be eligible if:** - You do not have the right number of prior treatment lines for the cohort you are applying for - You have serious uncontrolled medical conditions or inadequate organ function - You are unable to provide tumor tissue samples (in some cases this can be waived) 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

DRUGSI-B003

Administration by intravenous infusion


Locations(1)

Jilin Cancer Hospital

Changchun, Jilin, China

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NCT05924841


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