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

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Investigational Site 002, Los Angeles, California, United States, 90095

San Francisco

Investigational Site 009, San Francisco, California, United States, 94143

New Haven

Invesigational Site 004, New Haven, Connecticut, United States, 06510

Miami

Investigational Site 011, Miami, Florida, United States, 33136

Ocala

Investigational Site 010, Ocala, Florida, United States, 34474

Lafayette

Investigational Site 005, Lafayette, Indiana, United States, 47905

Boston

Investigational Site 001, Boston, Massachusetts, United States, 02215

Detroit

Investigational Site 014, Detroit, Michigan, United States, 48201

Saint Louis

Investigational Site 012, Saint Louis, Missouri, United States, 63110

Nashville

Investigational Site 008, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Asher Biotherapeutics, Inc.,

Medical Monitor, STUDY_DIRECTOR, Asher Biotherapeutics, Inc.

Study Record Dates

2027-05