AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
≥18 years at the time consent is signed.
Ability to provide written informed consent for the study.
ECOG PS of 0 or 1.
Participants of childbearing potential must not be pregnant at enrollment and agree to comply with contraception requirements. Participants with partners of childbearing potential must also comply with contraception requirements.
Disqualifiers
Has a diagnosis of immunodeficiency.
Prior stem cell, bone marrow, or organ transplant.
Known history of HIV infection. No HIV testing is required unless mandated by local health authority.
History of HBV (defined as HBV surface antigen reactive) or active HCV.
Trial design
Treatments tested in this trial
- AB821
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
Asher Biotherapeutics, Inc.
Collaborator
Source ClinicalTrials.gov