A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
NCT ID: NCT05653882
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
552 participants
INTERVENTIONAL
2023-01-04
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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etakafusp alfa (AB248) Monotherapy Dose-Escalation
etakafusp alfa (AB248) will be administered intravenously as a single agent
etakafusp alfa (AB248)
Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
etakafusp alfa (AB248) + pembrolizumab Combination Dose-Escalation
etakafusp alfa (AB248) and pembrolizumab will be administered intravenously
etakafusp alfa (AB248)
Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
pembrolizumab
Intravenous infusion of pembrolizumab
etakafusp alfa (AB248) Monotherapy Indication Expansion
etakafusp alfa (AB248) will be administered intravenously as a single agent in disease specific cohorts
etakafusp alfa (AB248)
Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
etakafusp alfa (AB248) + pembrolizumab Combination Indication Expansion
etakafusp alfa (AB248) and pembrolizumab will be administered intravenously in disease specific cohorts
etakafusp alfa (AB248)
Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
pembrolizumab
Intravenous infusion of pembrolizumab
Interventions
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etakafusp alfa (AB248)
Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
pembrolizumab
Intravenous infusion of pembrolizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Asher Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Asher Biotherapeutics, Inc.
Locations
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City of Hope
Duarte, California, United States
UCLA
Los Angeles, California, United States
UCSD
San Diego, California, United States
UCSF
San Francisco, California, United States
Yale
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Rutgers
New Brunswick, New Jersey, United States
NYU
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Intermountain Health
Murray, Utah, United States
Virginia Commonwealth
Richmond, Virginia, United States
Countries
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Other Identifiers
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KEYNOTE-E29
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-E29
Identifier Type: OTHER
Identifier Source: secondary_id
AB248-101
Identifier Type: -
Identifier Source: org_study_id
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