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NCT05653882 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Asher Biotherapeutics.

Active
Registry status
Phase 1
Development phase
552
Enrollment target
20
Study locations

NCT05653882 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is active but no longer recruiting, run by Asher Biotherapeutics. The registered enrollment target is 552 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05653882, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is active but no longer recruiting, sponsored by Asher Biotherapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
552 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Non-Small Cell Lung Cancer Melanoma Solid Tumor Renal Cell Carcinoma Squamous Cell Carcinoma of Head and Neck

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, categorized as Phase 1. The registered enrollment target is 552 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (16% lower). The listed sponsor is Asher Biotherapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.

NCT05653882 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Massachusetts.

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: Non-Small Cell Lung Cancer, Melanoma, Solid Tumor, Renal Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck.

What interventions are being tested in trial NCT05653882?

The interventions under investigation include: pembrolizumab (BIOLOGICAL), etakafusp alfa (AB248) (BIOLOGICAL).

Who is sponsoring clinical trial NCT05653882?

This trial is sponsored by Asher Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.