ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-01-04

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05653882

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Principal Investigator

Medical Monitor

STUDY_DIRECTOR

Asher Biotherapeutics, Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Asher Biotherapeutics, Inc.

Medical Monitor, STUDY_DIRECTOR, Asher Biotherapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-04

Study Completion Date2027-05

Study Record Updates

Study Start Date2023-01-04

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

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