Treatment of Recurrent GBM With APG-157 Via Expanded Access

January 29, 2024 updated by: Aveta Biomics, Inc.
This expanded access request will evaluate APG-157, a botanical drug under development for other cancers, as potential treatment for recurrent Glioblastoma multiforme (GBM) patients.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

Glioblastoma patients with disease recurrence after primary, currently approved primary treatments have limited options. Therefore, this expanded access trial is designed to test a new therapeutic option for these patients.

Patients who have progressed on a combination of both Temozolomide and Tumor Treating Field (Optune) or as single treatment Temozolomide (TMZ) OR Tumor Treating Fields (Optune) are eligible to receive APG-157. During APG-157 dosing, TMZ or Optune may be concurrently given at the decision of the Principal Investigator. APG-157 will be given until disease progression or intolerance by the patient.

Radiation followed by adjuvant Temozolomide for 6 to 12 months which is a current standard of care (SOC). Upon progression of this disease after SOC treatment, there are very limited further options for these patients. This expanded access administration will evaluate the potential of APG-157, a novel drug under development for head and neck cancer, as a potential treatment for these recurrent glioblastoma patients.

Brief Description of Objectives:

  • Improve six-month progression-free survival (PFS) and overall survival (OS) of the patients eligible for the treatment under Expanded Access protocol.
  • Improvement in Quality of Life
  • Achievements of above two objectives without any Serious Adverse Events (SAEs) and adverse drug-drug interactions.

Brief Description of Plans for Efficacy Assessment:

  • Improvement in Quality of Life
  • Efficacy will be assessed using Imaging (objective tumor response using Response Assessment in Neuro-Oncology criteria (RANO), hematological assessment, and tolerance.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • This study will enroll patients with histologically confirmed glioblastoma (GBM).
  • Patients must have received prior treatment with standard first-line therapy for GBM, including maximal surgical resection and postoperative external-beam radiotherapy or Tumor Treating Fields (Optune). Concurrent chemoradiation with TMZ or Tumor Treating Field (Optune) is allowed but not mandatory.
  • Patients are eligible for enrollment only if they have unequivocal evidence of tumor recurrence/progression by MRI a minimum of 12 weeks following completion of radiation therapy or TMZ-Radiotherapy or Optune. Patients who have received prior bevacizumab or other anti-vascular endothelial growth factor(anti-VEGF) agents are not eligible to enroll.
  • Baseline MRI should be performed within 28 days prior to enrollment.
  • Other key inclusion criteria include Eastern Cooperative Oncology Group (ECOG) status of 0-1 (KPS ≥ 70%) and adequate bone marrow, hepatic, and renal function at baseline.

Exclusion Criteria:

  • Patients with severe neutropenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aveta Biomics, Inc.

Investigators

  • Principal Investigator: Ekokobe Fonkem, DO, Baylor Scott & White

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

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSW AVTA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma

Clinical Trials on APG-157

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe