Clinical Trial

AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Study acronym: Asher-BioAB821
Recruiting Phase 1
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Summary
This study is a first-in-human, open-label, nonrandomized, single center Phase 1 dose-escalation study to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of AB821 monotherapy given every 2 weeks (Q2W) or every 3 weeks (Q3W) in participants with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. Immune-responsive solid tumors are defined as those for which immune checkpoint inhibitors form part of the standard-of-care therapy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-16; most recent amendment 2026-06-12.
Status change: Not Yet Recruiting → Recruiting 2025-08-11
Trial Details
NCT Number NCT07027488
Lead Sponsor Yale University
Collaborators: Asher Biotherapeutics, Inc.
Conditions Advanced Melanoma and Normal or Impaired, Advanced Melanoma
Enrollment 50 participants
Start Date 2025-08-05
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-16