NCT05653882Active, not recruitingPhase 1
A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 552 (estimated)
- First submitted
- 30 Nov 2022
- Start date
- 4 Jan 2023
- Primary completion date
- Aug 2026
- Lead sponsor
- Asher Biotherapeutics, Inc.
- Diseases
- Head and neck cancer, Kidney cancer, Melanoma, Lung cancer
- NCT number
- NCT05653882
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 552
- From 4 Jan 2023 to the primary completion date, Aug 2026
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years.
- 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
Other illness
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has an active infection requiring systemic therapy.
Other
- Has a diagnosis of immunodeficiency.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Inability to comply with study and follow-up procedures.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Intermountain Health Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Ocala Oncology Center Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Providence Cancer Institute Franz Clinic Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| UCSD Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.