Phase 1 Study of AB821 to Assess Safety and Anti-Cancer Effects in Adults With Advanced Melanoma and Other Immune-Responsive Solid Tumors

What this Trial Is About

Researchers are evaluating AB821, an investigational drug, in adults with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. This first-in-human, open-label Phase 1 study aims to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of AB821 given every 2 or 3 weeks. Participants with melanoma must have previously received PD1L1 inhibitors, while those with other tumors must have had prior systemic treatment including or excluding PD1L1 inhibitors. Participants receive AB821 as a 30-minute intravenous infusion every 14 or 21 days, with dosing based on body weight. The study includes dose-escalation cohorts to find the maximum tolerated dose or maximum administered dose and select doses for future studies. Additional participants may join backfill cohorts to further assess safety and efficacy. The study has phases including screening, treatment, an end-of-treatment visit, 30-, 60-, 90-day safety follow-up, and long-term follow-up to monitor ongoing safety and disease status. During the study, participants undergo various assessments such as monitoring for dose-limiting toxicities, serious adverse events, and treatment-emergent adverse events for approximately two years after the first dose. Researchers evaluate pharmacokinetics and immunogenicity, as well as tumor response and survival outcomes. If disease progression occurs, participants may continue treatment if deemed beneficial. Long-term follow-up collects data on safety, disease progression, survival, and subsequent therapies to understand the overall impact of AB821.

AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors