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ACTIVE NOT RECRUITING
NCT05653882
PHASE1

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

Sponsor: Asher Biotherapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

552

Start Date

2023-01-04

Completion Date

2027-05

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

etakafusp alfa (AB248)

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

BIOLOGICAL

pembrolizumab

Intravenous infusion of pembrolizumab

Locations (20)

City of Hope

Duarte, California, United States

UCLA

Los Angeles, California, United States

UCSD

San Diego, California, United States

UCSF

San Francisco, California, United States

Yale

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Rutgers

New Brunswick, New Jersey, United States

NYU

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Intermountain Health

Murray, Utah, United States

Virginia Commonwealth

Richmond, Virginia, United States