Treatment of Recurrent GBM With APG-157 Via Expanded Access

BSW AVTA

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.

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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

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}

2024-01-30