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Clinical Trials in the USA / NCT05653882
Active, not recruiting Phase 1

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

NCT05653882 · tracked via the Priya Life Science USA tracker
Sponsor
Asher Biotherapeutics, Inc.
Phase
Phase 1
Started
2023-01-04
Last updated
2025-09-10

Condition(s) studied

Solid TumorNon Small Cell Lung CancerMelanomaSquamous Cell Carcinoma of Head and NeckRenal Cell Carcinoma

Investigational drug(s) / intervention(s)

etakafusp alfa (AB248)pembrolizumab

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

pembrolizumab: Intravenous infusion of pembrolizumab

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
City of Hope Duarte California
UCLA Los Angeles California
UCSD San Diego California
UCSF San Francisco California
Yale New Haven Connecticut
University of Miami Miami Florida
Ocala Oncology Center Ocala Florida
University of Chicago Medical Center Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
Karmanos Cancer Institute Detroit Michigan
Washington University St Louis Missouri
Rutgers New Brunswick New Jersey
NYU New York New York
Memorial Sloan Kettering Cancer Center New York New York
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
Providence Cancer Institute Franz Clinic Portland Oregon
Sarah Cannon Research Institute Nashville Tennessee
Intermountain Health Murray Utah
Virginia Commonwealth Richmond Virginia

On this site

📄 Keytruda (pembrolizumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05653882 on ClinicalTrials.gov ↗ ← All trials in the USA