Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma

NCT07349693 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EFBPOLZ-1
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition

Conditions

Recurrent Glioblastoma, IDH-Wildtype

Outcome Measures

Primary Outcomes (1)

• Median overall survival (OS)

  Median overall survival (OS) in recurrent glioblastoma patients (event-based)

  24 months

Secondary Outcomes (4)

• Tolerability and Safety Profile

  24 months

• Survival rate

  6, 9, 12, 18, and 24 months

• Median progression-free survival (PFS)

  24 months

• PFS rate

  6, 9, and 12 months

Study Arms (2)

Treatment Group (Cerebraca Wafer)

EXPERIMENTAL

Patients will receive surgical tumor resection, implantation of 6 Cerebraca Wafer (75 mg each, total dose of 450 mg (Z)-BP) at the time of surgery, followed by SOC TMZ therapy.

Drug: Cerebraca wafer; Drug: Temozolomide (for relapsed malignant glioma)

Comparative Group (Standard-of-Care)

ACTIVE COMPARATOR

Patients will receive surgical tumor resection, followed by SOC TMZ therapy.

Drug: Temozolomide (for relapsed malignant glioma)

Interventions

Temozolomide (for relapsed malignant glioma) DRUG

TMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma.

Comparative Group (Standard-of-Care); Treatment Group (Cerebraca Wafer)

Cerebraca wafer DRUG

Cerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant)

Treatment Group (Cerebraca Wafer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be aged ≥ 18, regardless of gender
• Subject must have histologically confirmed glioblastoma with:
• Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide/radiation)
• Current presentation being first or second recurrence only
• Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria
• Subject must be deemed eligible for gross total resection of contrast-enhancing MRI-identified lesion by neurosurgeon's pre-operative assessment, according to RANO II
• Subject must have Karnofsky Performance Status (KPS) ≥ 70
• Subject must have recovered from prior therapy toxicities with adequate organ function:
• Hemoglobin ≥ 8 g/dL
• Platelets ≥ 100,000/mm3
• White blood cell count (WBC) ≥ 3,000 cells/mm3
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Absolute lymphocyte count (ALC) ≥ 1,000 cells/mm3
• Coagulation tests (prothrombin time \[PT\], activated partial thromboplastin time \[APTT\], International Normalized Ratio \[INR\]) ≤ 1.5 × ULN
• Total bilirubin (TBIL) \< 3 × ULN

You may not qualify if:

• Histological confirmation of oligodendroglioma or mixed glioma
• Presence of IDH or H3K27M mutation, or 1p19q co-deletion
• MRI-identified lesion meeting any criteria:
• Multi-focal (defined as 2 non-contiguous contrast enhancement areas \> 1 cm in 2 planes on fluid-attenuated inversion recovery, FLAIR or T2-weighted sequences)
• Presence of diffuse subependymal or leptomeningeal dissemination
• Contrast-enhancing lesion \> 6 cm in any dimension
• Tumor location unsuitable for surgical resection and Cerebraca Wafer implantation in the brain areas where surgical intervention would cause significant neurological deficits
• Prior bevacizumab treatment with uncontrollable tumor progression
• History of other malignancy within past 5 years
• Immunocompromised status or autoimmune conditions requiring systemic immunosuppressive therapy, with the following exceptions:
• Patients with autoimmune conditions may be eligible after individual assessment of the condition, its severity, and potential interaction with the Cerebraca Wafer.
• Patients with HIV infection are eligible if they:
• i. Have CD4+ T-cell counts ≥350 cells/μL ii. Are on stable anti-retroviral therapy iii. Have HIV viral load below the limit of quantification c. Patients with HBV infection are eligible if they: i. Are on appropriate suppressive anti-viral therapy prior to study enrollment ii. Have no evidence of hepatic decompensation d. Patients with history of HCV infection are eligible if they: i. Have completed curative anti-viral treatment with HCV viral load below the limit of quantification
• Active, uncontrolled infection or medical condition that could compromise safety and efficacy assessment

Sponsors & Collaborators

• Everfront Biotech Co., Ltd.: lead

Study Sites (1)

Legorreta Cancer Center Warren Alpert Medical School of Brown University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jui Hao Lee, PhD

CONTACT

+886 2 2756-3796; juihaolee@efbiotech.com

Jen Wei Liu, PhD

CONTACT

+886 2 2756-3796; davidliu@efbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 20, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)