ERC1671 + GM-CSF + Cyclophosphamide for Glioblastoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByDaniela A. Bota, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Epitopoietic Research Corporation

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with recurrent/progressive, bevacizumab naïve glioblastoma multiforme and gliosarcoma (World Health Organization (WHO) grade IV malignant gliomas, GBM).

Eligibility Criteria

This trial is for adults over 18 with glioblastoma or gliosarcoma who are experiencing their first or second relapse. They must have had prior surgery, radiation, and chemotherapy with temozolomide, be in good physical condition (KPS ≥ 70%), and have a life expectancy of more than 12 weeks. Participants should not currently have severe treatment-related side effects except hair loss and certain blood conditions.

Inclusion Criteria

I have a confirmed diagnosis of a high-grade brain tumor.

I have been diagnosed with a high-grade brain tumor.

I am mostly able to care for myself.

I've had surgery, radiation, and TMZ for my glioblastoma.

I am 18 years old or older.

My cancer can be measured in two different dimensions before surgery.

I am on a specific dose of corticosteroids.

My glioblastoma has returned for the first or second time.

Exclusion Criteria

I haven't had any major abdominal issues like fistula, perforation, or abscess in the last 6 months.

My cancer has spread to the lining of my brain and spine.

I have or might have cancer that has spread.

I have previously received treatments targeting blood vessel growth in cancer.

I am not allergic to bevacizumab or its components.

I do not have any major health conditions or infections.

I have high blood pressure that isn't managed and have had brain issues due to it.

I am not pregnant or breastfeeding and can follow birth control requirements.

I am a man not willing to use birth control.

Participant Groups

The study tests if ERC1671 combined with GM-CSF and Cyclophosphamide improves outcomes when added to Bevacizumab compared to placebo injections/pills plus Bevacizumab in patients with recurrent/progressive glioblastoma multiforme that haven't been treated with Bevacizumab before.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: (ERC1671/GM-CSF/Cyclophosphamide)+bevacizumab/bevacizumab biosimilarExperimental Treatment4 Interventions

ERC1671 and GM-CSF will be intradermally administered, while cyclophosphamide is orally administered. GM-CSF dose is 500mcg fixed dose and cyclophosphamide dose is 50 mg/day. Bevacizumab or approved bevacizumab biosimilars are administered as standard of care at 10 mg/kg every 2 weeks. The treatment will be repeated every 28 days until progression of disease or intolerance.

Group II: (Placebo Injection/Placebo Pill) +Bevacizumab/bevacizumab biosimilarPlacebo Group3 Interventions

The control group will have the same study schedule except that the patients will be receiving the Oral Control on the Cyclophosphamide treatment days and the Injectable control on the GM-CSF + ERC1671 treatment days. The control group will receive bevacizumab or approved bevacizumab biosimilar just as the active treatment group above. The treatment will be repeated every 28 days until progression of disease or intolerance.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: