Treatment of Recurrent GBM With APG-157 Via Expanded Access

NCT05551013 | Unknown

• 1 other identifier: BSW AVTA
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioblastoma; Glioblastoma Multiforme

Keywords

Temozolomide; Tumor Treating Field; Optune; Progression

Interventions

APG-157 DRUG

APG-157 is an orally administered drug encased in a hydrogel pastille. Arms: * Ongoing Stupp protocol (will receive concurrent TMZ + APG-157) * Progression post TMZ (will receive APG-157 only) * Ongoing Optune (will receive concurrent Optune + APG-157) * Progression post Optune (will receive APG-157 only)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with severe neutropenia

Sponsors & Collaborators

• Aveta Biomics, Inc.: lead

MeSH Terms

Conditions

Glioblastoma; Disease Progression

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 22, 2022
• Last Updated: August 9, 2024

Record last verified: 2024-08