Actively Recruiting
Phase I Study of AK138D1 to Assess Safety and Early Effectiveness in Adults With Advanced Solid Cancers
Led by Akeso · Updated on 2025-12-15
200
Participants Needed
1
Research Sites
83 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating AK138D1 in a Phase I clinical trial involving patients with advanced malignant tumors who have not responded to standard treatments. This study aims to assess the safety, tolerability, immune response, and possible anti-tumor effects of AK138D1 to find the best dose for future research. The trial focuses on adults up to 75 years old with measurable cancer lesions and good overall health status. Participants will receive AK138D1 through intravenous infusion at specified dose levels. The study includes a dose-escalation phase to identify the safest and most effective dose. Patients will be closely monitored during treatment for any side effects and responses. The number of participants will depend on observed safety and effectiveness results. During the trial, participants will undergo assessments such as imaging scans to measure tumor size, blood tests to monitor drug levels and immune response, and evaluations of side effects. The primary outcomes include tracking adverse events and dose-limiting toxicities over about two years. Secondary outcomes observe drug concentration, immune reactions, tumor response rates, disease control, survival times, and overall patient survival. Careful monitoring ensures participant safety throughout the study period.
CONDITIONS
Brief Title
A Study of AK138D1 in Advanced Malignant Tumors
Research Team
W
Wenting Li, MD
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