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Solid TumorPhase 1NCT05653882

A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors

A Phase 1 study testing etakafusp alfa (AB248) and pembrolizumab in people with Solid Tumor and Non Small Cell Lung Cancer, run by Asher Biotherapeutics, Inc. at 20 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Non Small Cell Lung Cancer, Melanoma
What is being tested?
etakafusp alfa (AB248) and pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
552 participants
Where
20 sitesUnited States
Study dates
4 Jan 2023to May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • UCLA

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33136

  • Intermountain Health

    Murray, Utah, 84107

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Rutgers

    New Brunswick, New Jersey, 08901

  • Yale

    New Haven, Connecticut, 06510

  • NYU

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Virginia Commonwealth

    Richmond, Virginia, 23298

  • UCSD

    San Diego, California, 92037

  • UCSF

    San Francisco, California, 94143

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.

Being tested
etakafusp alfa (AB248), pembrolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Melanoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • etakafusp alfa (AB248)Biological

    Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug

  • pembrolizumabBiological

    Also called KEYTRUDA®

    Intravenous infusion of pembrolizumab

Study groups in NCT05653882
Study groupRoleWhat they receive
etakafusp alfa (AB248) Monotherapy Dose-EscalationExperimentaletakafusp alfa (AB248) will be administered intravenously as a single agent
Receives: Biological: etakafusp alfa (AB248)
etakafusp alfa (AB248) + pembrolizumab Combination Dose-EscalationExperimentaletakafusp alfa (AB248) and pembrolizumab will be administered intravenously
Receives: Biological: etakafusp alfa (AB248); Biological: pembrolizumab
etakafusp alfa (AB248) Monotherapy Indication ExpansionExperimentaletakafusp alfa (AB248) will be administered intravenously as a single agent in disease specific cohorts
Receives: Biological: etakafusp alfa (AB248)
etakafusp alfa (AB248) + pembrolizumab Combination Indication ExpansionExperimentaletakafusp alfa (AB248) and pembrolizumab will be administered intravenously in disease specific cohorts
Receives: Biological: etakafusp alfa (AB248); Biological: pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Dose-Limiting Toxicities (DLTs)

    Based on toxicities observed

    Measured: From Study Day 1 through up to Day 21, Day 28, or Day 42

  2. Frequency of Serious Adverse Events (SAEs)

    Based on toxicities observed

    Measured: Signed consent up to 90 days after discontinuing study treatment

  3. Frequency of Treatment Emergent Adverse Events (TEAEs)

    Based on toxicities observed

    Measured: Study Day 1 up to 90 days after discontinuing study treatment

  4. Frequency of Adverse Events of Special Interest (AESIs)

    Based on toxicities observed

    Measured: Study Day 1 up to 90 days after discontinuing study treatment

  5. Frequency of Adverse Events (AEs) leading to dose interruption or treatment discontinuation and death

    Based on toxicities observed

    Measured: Signed consent up to 90 days after discontinuing study treatment

Secondary outcomes (11)

  1. Objective Response Rate (ORR) according to RECIST version 1.1

    Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.

    Measured: Study Day 1 up to approximately 24 months

  2. Duration of Response (DOR) according to RECIST version 1.1

    Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression.

    Measured: Study Day 1 up to approximately 24 months

  3. Disease Control Rate (DCR) according to RECIST version 1.1

    Defined as the percentage of patients who have achieved CR, PR, or stable disease.

    Measured: Study Day 1 up to approximately 24 months

  4. Progression-Free Survival (PFS) according to RECIST version 1.1

    Defined as the time from first dose of AB248 to first documentation of radiographic disease progression or death, whichever occurs first

    Measured: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months

  5. Overall Survival (OS) according to RECIST version 1.1

    Defined as the time from first dose of AB248 to the date of death.

    Measured: Study Day 1 up to time of death, assessed up to approximately 24 months

  6. Maximum observed blood concentration (Cmax) of AB248

    Defined as assessments for measuring maximum blood concentration of AB248

    Measured: Study Day 1 up to approximately 24 months

  7. AUC Area under the Plasma Concentration versus Time Curve (AUC) of AB248

    Defined as assessments for evaluating the Area Under the Concentration-Time Curve (AUC)

    Measured: Study Day 1 up to approximately 24 months

  8. Elimination half-life (t1/2) of AB248

    Defined as the time required for half of the drug to be eliminated from the blood

    Measured: Study Day 1 up to approximately 24 months

  9. Quantification of peripheral blood CD8+ T cell pharmacodynamics

    Defined as the volumetric enumeration of CD8+ T cells in whole blood as assessed by flow cytometry

    Measured: Study Day 1 up to approximately 24 months

  10. Changes in CD8+ T cell density in tumor tissues

    Defined as changes in immune-staining for CD8+ T cells density in tumor tissue from patients providing paired biopsies.

    Measured: Study Day 1 to approximately 1 month

  11. Frequency of anti-drug antibodies (ADA)s to AB248

    Defined as the frequency of ADA formation for immunogenicity assessments evaluated during study treatment up until 30 days after the final dose of study treatment.

    Measured: Study Day 1 up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start4 Jan 2023
  3. Primary completionAug 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
552 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05653882
Sponsor's protocol ID
AB248-101
Other IDs
KEYNOTE-E29, MK-3475-E29
Status last verified
Sep 2025
First submitted
30 Nov 2022
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing etakafusp alfa (AB248) and pembrolizumab in people with Solid Tumor and Non Small Cell Lung Cancer, run by Asher Biotherapeutics, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Dose-Limiting Toxicities (DLTs) (time frame: From Study Day 1 through up to Day 21, Day 28, or Day 42). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05653882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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