A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 10, 2025 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Asher Biotherapeutics, Inc.
- Interventions being studied
- Biological: etakafusp alfa (AB248); Biological: pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- UCLALos Angeles, California
- UCSDSan Diego, California
- UCSFSan Francisco, California
- YaleNew Haven, Connecticut
- University of MiamiMiami, Florida
- Ocala Oncology CenterOcala, Florida
- University of Chicago Medical CenterChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Karmanos Cancer InstituteDetroit, Michigan
- Washington UniversitySt Louis, Missouri
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 10, 2025. Always confirm current availability with the study team.