Actively Recruiting
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Led by Yale University · Updated on 2026-02-25
50
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
A
Asher Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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) 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.
CONDITIONS
Official Title
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of consent
- Able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- If of childbearing potential, not pregnant and willing to use contraception; partners of childbearing potential must also comply with contraception
- Adequate organ function based on recent laboratory tests within 7 days before treatment start, including specific blood counts and liver and kidney function
- Life expectancy of at least 12 weeks
- For melanoma: unresectable or metastatic disease that progressed after PD-1/PD-L1 checkpoint blockade treatment
- For other tumors: recurrent metastatic or locally advanced solid tumors (including NSCLC, renal cell carcinoma, Merkel-cell carcinoma, bladder cancer, or squamous cell carcinoma of the head and neck) not suitable for curative surgery or radiation, with prior systemic therapy
- Measurable disease according to RECIST v1.1 by local investigator
You will not qualify if you...
- Diagnosis of immunodeficiency
- Prior stem cell, bone marrow, or organ transplant
- Known HIV infection
- History of hepatitis B or active hepatitis C infection
- Active autoimmune disease requiring systemic treatment within the past 2 years (replacement therapy allowed)
- Active Grade 2 or higher diarrhea or enterocolitis
- Known active central nervous system metastases or carcinomatous meningitis, except stable treated brain metastases
- Any other cancer within the past 3 years except certain fully treated or localized tumors
- Regular use or recent history (within 1 year) of illicit drug or substance abuse including alcohol
- Significant heart disease affecting daily activities, recent heart attack, or worsening thrombosis
- Prolonged QTcF interval over 470 ms
- Any condition or therapy that might interfere with study participation or results
- Active infection requiring systemic therapy
- Severe hypersensitivity to study drug components
- Use of high-dose systemic steroids or immunosuppressive therapy within 7 days before treatment
- More than 5 prior systemic treatments for recurrent/metastatic disease
- Recent radiotherapy within 2 weeks or history of radiation pneumonitis
- History of severe autoimmune myocarditis or Guillain-Barre Syndrome
- Congestive heart failure with ejection fraction below 40%
- For NSCLC only: recent lung radiation over 30 Gy within 6 months
- Prior IL-21 based therapy or AB248 treatment
- Recent systemic anticancer therapy within 4 weeks or 5 half-lives
- Incomplete recovery from major surgery
- Live or live attenuated vaccine within 30 days
- Use of prohibited medications
- Positive pregnancy test within 14 days prior to treatment for those of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
S
Stephanie Ladd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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