Actively Recruiting
An Open-Label Phase 1 Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AB821 in Adults with Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Led by Yale University · Updated on 2026-02-25
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
A
Asher Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating AB821, an investigational drug given by intravenous infusion every two weeks, 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, how the drug is processed in the body, immune response, and early antitumor effects. The study focuses on tumors that are typically treated with immune checkpoint inhibitors and includes participants who have previously received such treatments. Participants will receive AB821 as a 30-minute IV infusion on Day 1 of each 14-day cycle, with dose escalation cohorts to determine the maximum tolerated or maximum administered dose and recommend dosing for future studies. Dose escalation will proceed cautiously with monitoring for dose-limiting toxicities. Additional participants may be enrolled in backfill cohorts to further assess safety and efficacy. The study includes a screening phase, treatment phase, end of treatment visit, safety follow-up at 30, 60, and 90 days, and a long-term follow-up phase to monitor ongoing safety, survival, and subsequent therapies. During the study, participants will be closely monitored for side effects, immune response, and tumor response using scans and laboratory tests. Those showing disease progression by RECIST criteria may continue treatment if tolerated and beneficial. Researchers will track adverse events, drug levels in the blood, and various measures of tumor response over approximately two years. Safety follow-up visits and long-term monitoring will continue after treatment ends to ensure comprehensive assessment of treatment effects and participant well-being.
CONDITIONS
Brief Title
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time consent is signed
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Participants of childbearing potential must not be pregnant and must agree to contraception requirements
- Adequate organ function verified by lab tests within seven days prior to treatment
- Life expectancy of at least 12 weeks as judged by the investigator
- For melanoma: unresectable or metastatic disease progressing after PD-1/PD-L1 inhibitor treatment
- For other tumors: recurrent metastatic or locally advanced solid tumor not curable by surgery or radiation, with prior systemic anticancer therapy
- Measurable disease based on RECIST v1.1 criteria as assessed locally
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 in the past two years
- Active grade 2 or higher diarrhea or enterocolitis
- Active central nervous system metastases or carcinomatous meningitis unless stable and off steroids
- Other malignancies within the past three years that may interfere with study endpoints
- Recent substance abuse or illicit drug use
- Clinically significant heart disease affecting daily activities
- Recent acute myocardial infarction within six months
- Recent thrombosis within six months
- QTcF interval greater than 470 ms
- Conditions or therapies that may interfere with study participation or results
- Active infection requiring systemic therapy
- Severe hypersensitivity to study drug components
- Chronic systemic steroid or immunosuppressive therapy exceeding specified limits
- More than five prior systemic treatments in recurrent/metastatic setting
- Recent radiotherapy within two weeks or history of radiation pneumonitis
- History of severe autoimmune myocarditis or Guillain Barre Syndrome
- Congestive heart failure with ejection fraction below 40%
- NSCLC patients with recent high-dose lung radiation
- Prior IL-21 based therapy or AB248 treatment
- Recent systemic anticancer therapy within four weeks or five half-lives
- Unrecovered major surgery
- Recent live or live attenuated vaccination within 30 days
- Use of prohibited concomitant medications
- Positive pregnancy test within 14 days prior to treatment for participants of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants receive AB821 via IV infusion on Day 1 of each 14-day cycle for up to two years. Treatment may continue beyond disease progression if clinical benefit is observed and approved by the investigator.
IV infusions every 2 weeks
Duration - Approximately 3 months
Participants are monitored for safety after end of treatment, including follow-up visits at 30, 60, and 90 days post treatment.
3 visits (30, 60, and 90 days post treatment)
Duration - Up to approximately two years after first dose
Ongoing monitoring of safety, disease progression, survival status, and subsequent anticancer therapies after safety follow-up phase.
Visits as needed for long-term monitoring
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
S
Stephanie Ladd
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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