Phase 1 Study of SKB571 for Injection to Evaluate Safety and Early Anti-Tumor Effects in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting a first-in-human, phase 1, open-label study to evaluate SKB571 in adults with advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, immune response, and preliminary anti-tumor activity of this treatment. This early-phase trial is important to understand how the drug behaves in the body and its potential effects on tumors. Participants will receive SKB571 by injection every three weeks. Treatment will continue until the disease progresses as shown by scans, unacceptable side effects occur, the participant passes away, or treatment is stopped for other reasons. This study uses a dose escalation approach to find the appropriate dosage while monitoring safety. Throughout the study, participants will undergo various assessments including measuring responses to treatment, monitoring survival, and checking for side effects up to 24 months. The primary outcome is to track dose-limiting toxicities within 21 days after dosing. Researchers will also evaluate tumor response, progression-free survival, duration of response, and overall survival. Participants will be closely monitored with medical exams and tests to ensure safety and collect data on how the treatment affects their cancer.

A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors