D2C7-IT + Atezolizumab for Glioma

Recruiting in Palo Alto (17 mi)

Overseen byDaniel Landi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Darell Bigner

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a phase 1 study of atezolizumab in combination with D2C7-IT, a dual-specific monoclonal antibody (mAB) with a high affinity for both EGFRwt- and EGFRvIII-expressing cells, in patients with recurrent World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.

Eligibility Criteria

Adults with recurrent grade IV malignant glioma who have adequate organ function, are not pregnant or breastfeeding, and can undergo MRI. They must be able to sign informed consent, have a Karnofsky Performance Score of at least 70%, and meet specific blood count criteria. Excluded are those with immunodeficiency, severe lung or diabetes issues, certain allergies, recent immunotherapy or radiation unless showing progression, active infections or heart disease.

Inclusion Criteria

Hemoglobin ≥ 9 g/dl prior to biopsy

Neutrophil count ≥ 1000 cells/mm3 prior to biopsy

I am able to care for myself but may not be able to do active work.

+14 more

Exclusion Criteria

My tumor has or might have a specific genetic feature, and I've had chemotherapy before.

Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate

I have worsening muscle weakness and muscle loss in my arms and legs.

+18 more

Participant Groups

The trial is testing the combination of Atezolizumab (an immune checkpoint inhibitor) with two different concentrations of D2C7-IT (a monoclonal antibody targeting cancer cells) in patients with recurring brain tumors. It's a phase 1 study focusing on safety and how well these treatments work together.

2Treatment groups

Experimental Treatment

Group I: D2C7-IT (6920 ng/mL) + AtezolizumabExperimental Treatment2 Interventions

Single D2C7-IT convection-enhanced delivery (CED) infusion (6920 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years

Group II: D2C7-IT (4613.2 ng/mL) + AtezolizumabExperimental Treatment2 Interventions

Single D2C7-IT convection-enhanced delivery (CED) infusion (4613.2 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: