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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.
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

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
University of Chicago Medical Center
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ChicagoUnited StatesUnknown status
Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
UCLA
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Los AngelesUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Intermountain Health
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MurrayUnited StatesUnknown status
Sarah Cannon Research Institute
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NashvilleUnited StatesUnknown status
Rutgers
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New BrunswickUnited StatesUnknown status
Yale
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New HavenUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
NYU
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New YorkUnited StatesUnknown status
Ocala Oncology Center
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OcalaUnited StatesUnknown status
Providence Cancer Institute Franz Clinic
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PortlandUnited StatesUnknown status
Virginia Commonwealth
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RichmondUnited StatesUnknown status
UCSD
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San DiegoUnited StatesUnknown status
UCSF
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San FranciscoUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.