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
3 other identifiers
interventional
552
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedStudy Start
First participant enrolled
January 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
September 10, 2025
September 1, 2025
3.6 years
November 30, 2022
September 3, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Frequency of Dose-Limiting Toxicities (DLTs)
Based on toxicities observed
From Study Day 1 through up to Day 21, Day 28, or Day 42
Frequency of Serious Adverse Events (SAEs)
Based on toxicities observed
Signed consent up to 90 days after discontinuing study treatment
Frequency of Treatment Emergent Adverse Events (TEAEs)
Based on toxicities observed
Study Day 1 up to 90 days after discontinuing study treatment
Frequency of Adverse Events of Special Interest (AESIs)
Based on toxicities observed
Study Day 1 up to 90 days after discontinuing study treatment
Frequency of Adverse Events (AEs) leading to dose interruption or treatment discontinuation and death
Based on toxicities observed
Signed consent up to 90 days after discontinuing study treatment
Secondary Outcomes (11)
Objective Response Rate (ORR) according to RECIST version 1.1
Study Day 1 up to approximately 24 months
Duration of Response (DOR) according to RECIST version 1.1
Study Day 1 up to approximately 24 months
Disease Control Rate (DCR) according to RECIST version 1.1
Study Day 1 up to approximately 24 months
Progression-Free Survival (PFS) according to RECIST version 1.1
Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Overall Survival (OS) according to RECIST version 1.1
Study Day 1 up to time of death, assessed up to approximately 24 months
- +6 more secondary outcomes
Study Arms (4)
etakafusp alfa (AB248) Monotherapy Dose-Escalation
EXPERIMENTALetakafusp alfa (AB248) will be administered intravenously as a single agent
etakafusp alfa (AB248) + pembrolizumab Combination Dose-Escalation
EXPERIMENTALetakafusp alfa (AB248) and pembrolizumab will be administered intravenously
etakafusp alfa (AB248) Monotherapy Indication Expansion
EXPERIMENTALetakafusp alfa (AB248) will be administered intravenously as a single agent in disease specific cohorts
etakafusp alfa (AB248) + pembrolizumab Combination Indication Expansion
EXPERIMENTALetakafusp alfa (AB248) and pembrolizumab will be administered intravenously in disease specific cohorts
Interventions
Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
Intravenous infusion of pembrolizumab
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asher Biotherapeutics, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (20)
City of Hope
Duarte, California, 91010, United States
UCLA
Los Angeles, California, 90095, United States
UCSD
San Diego, California, 92037, United States
UCSF
San Francisco, California, 94143, United States
Yale
New Haven, Connecticut, 06510, United States
University of Miami
Miami, Florida, 33136, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University
St Louis, Missouri, 63110, United States
Rutgers
New Brunswick, New Jersey, 08901, United States
NYU
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Intermountain Health
Murray, Utah, 84107, United States
Virginia Commonwealth
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Asher Biotherapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 16, 2022
Study Start
January 4, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share