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

Last updated: February 21, 2025
Sponsor: Asher Biotherapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Renal Cell Carcinoma

Head And Neck Cancer

Cancer/tumors

Treatment

Pembrolizumab

etakafusp alfa (AB248)

AB248

Clinical Study ID

NCT05653882
AB248-101
KEYNOTE-E29
MK-3475-E29
  • Ages > 18
  • All Genders

Study 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. The study will consist of a dose escalation and a dose expansion stage.

Eligibility Criteria

Inclusion

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 siteInvestigator/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 thetype being evaluated in individual cohorts

Exclusion

Exclusion Criteria:

  • Has a diagnosis of immunodeficiency.

  • Has a history of a previous, additional malignancy, unless potentially curativetreatment 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 2years.

  • 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 withpembrolizumab, another monoclonal antibody, or has history of any hypersensitivityto any components of the study treatments or any of their excipients.

  • Has received prior systemic anticancer therapy including investigational agentswithin 4 weeks (or, if shorter, within 5 half-lives for kinase inhibitors) prior tofirst dose of study treatment.

  • Has received prior radiotherapy within 2 weeks of start of study treatment or hashad a history of radiation pneumonitis.

  • Receiving chronic systemic steroid therapy or any other form of immunosuppressivetherapy within 7 days prior the first dose of study treatment.

  • Has received previous treatment with another agent targeting the IL-2, IL-7, orIL-15 receptors.

  • Is expected to require any other form of antineoplastic therapy while on study

Study Design

Total Participants: 552
Treatment Group(s): 4
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
January 04, 2023
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Investigational Site 002

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCSD

    San Diego, California 92037
    United States

    Active - Recruiting

  • Investigational Site 009

    San Francisco, California 94143
    United States

    Active - Recruiting

  • UCSF

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Invesigational Site 004

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Investigational Site 011

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Investigational Site 010

    Ocala, Florida 34474
    United States

    Active - Recruiting

  • Ocala Oncology Center

    Ocala, Florida 34474
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Investigational Site 005

    Lafayette, Indiana 47905
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Investigational Site 001

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Investigational Site 014

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Investigational Site 012

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Rutgers

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • NYU

    New York, New York 10016
    United States

    Active - Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Investigational Site 008

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Site Not Available

  • Virginia Commonwealth

    Richmond, Virginia 23298
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.