Safety of AM-928 Infusion in Advanced Solid Tumors
Summary
This is a Phase I, open-label, dose-escalation study for a novel cancer treatment, AM-928, intravenous infusion antibody for advanced solid tumor. The study is aimed to learn the safety, tolerability, pharmacokinetics, and preliminary efficacy profile of AM-928. The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. Seven dose levels are designed and each participant will be assigned to a specific dose regimen depending on the time of enrollment. In the study, each participant will receive AM-928 treatment cycles till meeting any treatment discontinuation criterion and be followed for safety and long-term survival. The whole study is expected to take approximately three years to complete.
Timeline
- Start
- 2023-07-14
- Primary completion
- 2026-06
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AM-928 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | AM-928 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | AM-928 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | AM-928 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | AM-928 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | AM-928 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | AM-928 | Monoclonal antibody | 15 mg/kg | Intravenous |