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Recruiting Phase 1 NCT06247657

A Phase I Study to Assess the Safety and Tolerability of BL0006 for Patients With Advanced Solid Tumours

Trial Parameters

Condition Advanced Solid Tumor
Sponsor Shanghai Best-Link Bioscience, LLC
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 66
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-03
Completion 2024-10
Interventions
BL0006

Brief Summary

This is the first in human study of BL0006, and the primary objective is to evaluate the safety and tolerability of BL0006 as a single agent in patients with advanced solid tumors.

Eligibility Criteria

Inclusion Criteria: 1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form. 2. Aged ≥ 18 years, male and female. 3. The dose-escalation stage: patients with histologically or cytologically confirmed, unresectable or metastatic advanced solid tumors that have failed despite standard therapy, for whom no standard therapy exists, or who have refused standard therapy. 4. The dose-expansion stage: patients with histologically or cytologically confirmed, unresectable or metastatic hepatocellular carcinoma (HCC) who are not suitable for surgery and local treatment, and who have failed despite standard therapy, or who have refused standard therapy. And other potential tumors (selection based on the results of BL0006-101 Study dose-escalation stage) that have failed despite standard therapy, for whom no standard therapy exists, or who have refused standard therapy. 5. Patients with at least one measurable lesion per R

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