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ACTIVE NOT RECRUITING Phase 1

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

NCT05653882 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BIOLOGICAL pembrolizumab
  • BIOLOGICAL etakafusp alfa (AB248)

Study Locations (20)

California

  • City of Hope — Duarte
  • UCLA — Los Angeles
  • UCSD — San Diego
  • UCSF — San Francisco

Florida

  • University of Miami — Miami
  • Ocala Oncology Center — Ocala

Massachusetts

  • Massachusetts General Hospital — Boston
  • Dana Farber Cancer Institute — Boston

New York

  • NYU — New York
  • Memorial Sloan Kettering Cancer Center — New York

Connecticut

  • Yale — New Haven

Illinois

  • University of Chicago Medical Center — Chicago

Michigan

  • Karmanos Cancer Institute — Detroit

Missouri

  • Washington University — St Louis

Trial Details

FieldValue
Enrollment Target 552 participants
Start Date 2023-01-04
Est. Completion 2027-05
Phase Phase 1

Sponsor

Asher Biotherapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05653882

The ClinicalTrials.gov registry entry for NCT05653882 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 552 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Asher Biotherapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions — of which pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05653882 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05653882 about?

NCT05653882 is a clinical study titled "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 c...

What is the current status of trial NCT05653882?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 552 participants. The study started on 2023-01-04. Estimated completion is 2027-05.

What conditions does trial NCT05653882 study?

This clinical trial studies the following conditions: Melanoma, Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05653882?

The interventions under investigation include: pembrolizumab (BIOLOGICAL), etakafusp alfa (AB248) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05653882?

This trial is sponsored by Asher Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05653882 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial