NCT06773507

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label clinical study aims to evaluate the safety, pharmacokinetic characteristics and preliminary efficacy of BC008-1A injection in subjects with advanced esophageal squamous cell carcinoma and advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma). There are two cohorts. Cohort 1 selects patients with advanced esophageal squamous cell carcinoma, and Cohort 2 selects subjects with advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) with a PD-L1 TPS (Tumor Proportion Score) of ≥1%. Cohort 1: Two dose groups will be set up. Subjects with advanced esophageal cancer will enter the low-dose group (900mg) or the high-dose group (1200mg) in parallel. Each subject will only receive the experimental drug of one dose group and will not participate in the studies of the other dose group. Cohort 2: Two dose groups will be set up. Subjects with advanced non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) will enter the low-dose group (900mg) or the high-dose group (1200mg) in parallel. Each subject will only receive the experimental drug of one dose group and will not participate in the studies of the other dose group. For both Cohort 1 and Cohort 2, BC008-1A injection will be administered once every 3 weeks, and 21 days will be regarded as one cycle. Subjects will continue to take the drug 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.

Conditions

• Advanced Esophageal Cancers
• Advanced Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
BIOLOGICAL	BC008-1A 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.
BIOLOGICAL	BC008-1A 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.

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-01-14
• Last updated: 2025-07-09

Locations

1 site across 1 country: China