NCT07027488
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Recruiting · Phase 1 · Yale University · registry updated 2026-06-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- ≥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.
- Adequate organ function as defined below. Specimens must be collected within seven days prior to the start of the study treatment (i.e., Cycle 1 Day 1 \[C1D1\]) including:
- ANC\> 1500/ul Platelet count\>100,000 Hb\>9 g/dl Calculated creatinine clearance\> 50 mL/min Total bilirubin greater than or equal to 1.5 x ULN or direct bilirubin greater than or equal to ULN for participants with total bilirubin \> 1.5 x ULN PT INR \> 1.5 x ULN unless on anticoagulation Albumin \> 3g/dl
Exclusion
- 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.
- Active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immune-suppressive treatment and is allowed.
- Active Grade ≥2 diarrhea or enterocolitis.