Actively Recruiting
Phase I Study of NBL-020 Injection to Assess Safety and Dosage in Adults with Advanced Malignant Tumors
Led by NovaRock Biotherapeutics, Ltd · Updated on 2024-03-26
200
Participants Needed
1
Research Sites
69 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of NBL-020 injection in adults with advanced malignant tumors. This Phase 1 study aims to find the dose limiting toxicity, maximum tolerable dose, recommended phase II dose, and the best dosing schedule for NBL-020. The study includes patients with various solid tumors and may include skin T-cell lymphoma in the dose expansion phase. The study has two parts dose escalation and dose expansion. The dose escalation starts with 0.1 mgkg of NBL-020 given intravenously once every 3 weeks, with possible increases up to 30 mgkg. The Safety Management Committee may adjust doses or dosing intervals based on safety and effectiveness data. In the dose expansion phase, the dose will be selected based on results from the escalation phase, with possible multiple doses evaluated. Participants will undergo regular assessments including monitoring for adverse events up to 30 days after the last dose, with follow-up lasting up to about 2 years. Blood tests will measure drug levels and immune response, and tumor tissue samples will be collected for biomarker testing. Researchers will also evaluate tumor response, disease control, progression-free and overall survival. Participants are monitored closely for safety throughout the study period.
CONDITIONS
Brief Title
A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.
Research Team
Y
Yilong Wu
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