AB821 for Skin Cancer

(Asher-BioAB821 Trial)

Overseen By Stephanie Ladd

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunodeficiency, HIV, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 28 days for initial dose-limiting toxicity assessment

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AB821, an experimental drug, for individuals with certain types of skin cancer and other tumors that respond well to immune-based therapies. Researchers are testing this drug in humans for the first time to determine its safety and effectiveness against tumors that have recurred or spread. Ideal participants have advanced melanoma that did not respond to previous treatments or other tumors typically treated with immune checkpoint inhibitors. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications, but it mentions that the use of any prohibited concomitant medications is not allowed. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that AB821 is likely to be safe for humans?

Earlier studies have tested AB821 to assess its safety for people. This treatment remains in the early testing phase, so detailed safety information is not yet available.

In these initial trials, researchers typically start with small doses and closely monitor participants for any side effects. This process helps determine how well people tolerate the treatment. Since AB821 is being tested in humans for the first time, the main focus is on safety and identifying the correct dose.

Currently, there is no specific information on side effects or negative reactions for AB821. However, early trials like this one are designed to carefully monitor for any potential issues. Participants in these studies help researchers understand how the treatment interacts with the body. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AB821 for skin cancer because it offers a new approach compared to traditional treatments like surgery, radiation, or topical therapies. AB821 is administered as an intravenous infusion, which allows for precise dosage control based on body weight, potentially reducing side effects. Most importantly, AB821 likely has a novel mechanism of action that targets cancer cells differently from existing options, which could mean better outcomes for patients who haven't responded well to current treatments.

What evidence suggests that AB821 might be an effective treatment for skin cancer?

Research suggests that AB821, the investigational treatment in this trial, might help treat skin cancer, including melanoma, which can be difficult to manage. This treatment aims to enhance the immune system's ability to fight cancer cells. Although limited information exists from human studies, early research has shown promise in targeting tumors that respond well to immune therapy. Immune therapy helps the body's immune system combat cancer. So far, AB821 has shown potential in early studies, but further research is needed to confirm its effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Harriet Kluger, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with advanced skin cancer, including melanoma and other tumors that respond to immune therapy. Participants must have a recurrence of their cancer after standard treatments.

Inclusion Criteria

I am 18 years old or older.

Ability to provide written informed consent for the study

Has measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology

Exclusion Criteria

I am currently being treated for an infection.

I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

My brain metastases are stable and I haven't needed steroids for 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AB821 monotherapy every 2 weeks in dose-escalation cohorts to determine MTD or MAD and select the recommended Phase 1b or Phase 2 dose

28 days for initial dose-limiting toxicity assessment

Bi-weekly visits for treatment

Safety Follow-up

30-, 60-, 90-day safety follow-up to monitor ongoing safety post end of treatment

90 days

3 visits (in-person or virtual)

Long-term Follow-up

Ongoing assessment of safety, disease progression, survival status, and subsequent anticancer therapies

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• AB821

Trial Overview AB821 is being tested as a new treatment given every two weeks for those with certain types of advanced or metastatic solid tumors. The study will look at safety, how the body processes the drug, its effects on the body and immune system, and if it can shrink tumors.

How Is the Trial Designed?

Group I: AB821 Experimental Treatment 1 Intervention

AB821 is intended to be administered as a 30-minute IV infusion every 2 weeks. Dosage is calculated per body weight.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Asher Biotherapeutics, Inc.

Industry Sponsor

Trials

1

Recruited

550+

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-06053

AB821 for the Treatment of Unresectable or Metastatic ... This phase I trial tests the safety, side effects, and best dose of AB821 in treating patients with melanoma that cannot be removed by surgery (unresectable) ...

2. withpower.com withpower.com/trial/phase-1-advanced-melanoma-and-normal-or-impaired-7-2025-41078

AB821 for Skin Cancer (Asher-BioAB821 Trial) This trial is for adults with advanced skin cancer, including melanoma and other tumors that respond to immune therapy. Participants must have a recurrence of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12175834/

A Review of Neoadjuvant PD-1 Inhibitors in the Setting of ... ... outcomes in skin cancer treatment. In this review, we will aim to delineate and briefly describe current studies being performed with PD-1 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9631247/

Real-world Treatment Patterns and Outcomes with ... During median follow-up of 52 weeks (IQR 27–97 weeks), overall response rate was 14.3%, and disease control rate was 53.6%. Median progression-free survival was ...

5. nyulangone.org nyulangone.org/news/study-shows-existing-drug-class-may-help-patients-skin-cancer-resists-standard-treatments

Study Shows that Existing Drug Class May Help Patients ... An NYU Langone study explains why many patients with a deadly form of skin cancer do not respond to the latest cancer treatments.

6. yalemedicine.org yalemedicine.org/clinical-trials/a-phase-i-trial-of-ab821-in-advanced-melanoma-and-other-checkpoint-sensitive-tumor-types

An Open-Label, Phase 1 Study to Investigate the Safety ... An Open-Label, Phase 1 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AB821 in Adult ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07027488?aggFilters=status%3Anot

AB821 in Adult Participants With Locally Advanced or ... This study is a first-in-human, open-label, nonrandomized, single center Phase 1 dose-escalation study to assess the safety, pharmacokinetics, pharmacodynamics, ...

8. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/a-phase-i-trial-of-ab821-in-advanced-melanoma-and-other-checkpoint-sensitive-tumor-types/

An Open-Label, Phase 1 Study to Investigate the Safety ... An Open-Label, Phase 1 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AB821 in Adult ...

9. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A1155

1048 AB821 is a CD8 + T cell selective IL-21 with ... AB821 is a next generation IL-21 with superior nonclinical anti-tumor activity over wild type IL-21. AB821 reduced CD8 + T cell exhaustion, resulting in potent ...