RecruitingPhase 1NCT06773507

Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors

An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics and Preliminary Efficacy of BC008-1A Injection in Subjects With Advanced Solid Tumors

Sponsor

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

Enrollment

80 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Non Small Cell Lung Cancer (NSCLC)Advanced Esophageal Cancers

Summary

The goal of this study is to learn if BC008-1A given 900mg or 1200mg intravenously once every 3 weeks is safe and effective to treat patients with advanced esophageal cancer or advanced non-small cell lung cancer. It will also learn about the safety and pharmacokinetics of BC008-1A.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new injection called BC008-1A in people with advanced cancers that have spread or cannot be removed by surgery, including esophageal cancer and non-small cell lung cancer. Researchers want to find out if the treatment is safe and what doses work best. **You may be eligible if...** - You have advanced esophageal squamous cell cancer or non-small cell lung cancer (squamous or adenocarcinoma) - Your cancer has spread or cannot be operated on - Standard treatments have not worked or are not available for you - You can provide a tissue sample from within the past year for testing **You may NOT be eligible if...** - You have not yet tried standard treatments - You are unable to provide tumor tissue for testing - You have certain serious health conditions that make experimental treatment too risky 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

BIOLOGICALBC008-1A 900mg

BC008-1A 900mg will be administered once every 3 weeks until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation.

BIOLOGICALBC008-1A 1200mg

BC008-1A 1200mg will be administered once every 3 weeks until disease progression occurs, or intolerable toxicity develops, or they are lost to follow-up, or withdraw their informed consent, or start a new anti-tumor treatment, or the investigator decides to withdraw them based on the subject's benefit situation.

Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

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NCT06773507

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