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New Immune-Boosting drug takes on tough cancers in first human trial

NCT ID NCT05653882

Disease control Sponsor: Asher Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tests an experimental drug called AB248, which aims to boost the body's cancer-fighting immune cells. It is given alone or with the approved immunotherapy Keytruda to adults with advanced solid tumors like lung cancer, melanoma, or kidney cancer. The main goals are to check safety, find the right dose, and see if tumors shrink. About 552 people will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
etakafusp alfa (AB248) and pembrolizumab
What this could lead to
If it works, this could point toward a new treatment option for certain advanced cancers like lung cancer or melanoma.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, so it is far from proving effectiveness. Side effects are unknown and the drug may not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 552 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years of age at the time consent is signed. * Has adequate end organ function per laboratory testing. * Pregnancy prevention requirements * Has measurable disease per RECIST 1.1 as assessed by the local site Investigator/radiology. * Has a performance status of 0 or 1 on Eastern Cooperative Oncology Group scale. * Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts Exclusion Criteria: * Has a diagnosis of immunodeficiency. * Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. * Has known active CNS metastases and/or carcinomatous meningitis. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * Has an active infection requiring systemic therapy. * Inability to comply with study and follow-up procedures. * Has had a severe hypersensitivity reaction (Grade ≥3) to treatment with pembrolizumab, another monoclonal antibody, or has history of any hypersensitivity to any components of the study treatments or any of their excipients. * Has received prior systemic anticancer therapy including investigational agents within 4 weeks (or, if shorter, within 5 half-lives for kinase inhibitors) prior to first dose of study treatment. * Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis. * Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment. * Has received previous treatment with another agent targeting the IL-2, IL-7, or IL-15 receptors. * Is expected to require any other form of antineoplastic therapy while on study

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma melanoma neoplasm non-small cell lung carcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma Non-small cell lung cancer Renal cell carcinoma Solid tumor Squamous cell carcinoma of head and neck

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Intermountain Health

    Murray, Utah, 84107, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • NYU

    New York, New York, 10016, United States

  • Ocala Oncology Center

    Ocala, Florida, 34474, United States

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213, United States

  • Rutgers

    New Brunswick, New Jersey, 08901, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • UCSD

    San Diego, California, 92037, United States

  • UCSF

    San Francisco, California, 94143, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Virginia Commonwealth

    Richmond, Virginia, 23298, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Yale

    New Haven, Connecticut, 06510, United States

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