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Monoclonal Antibodies

D2C7-IT + Atezolizumab for Glioma

Phase 1

Waitlist Available

Led By Daniel Landi, MD

Research Sponsored by Darell Bigner

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Score (KPS) ≥ 70%

Age ≥ 18 years of age at the time of entry into the study

Must not have

If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial

Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug in people with a certain type of brain tumor.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include allergic reactions to components in the drugs; increased risk for infection due to immune system suppression; possible worsening of autoimmune diseases; fatigue; liver enzyme changes; bleeding risks related to low platelet counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My brain tumor is a grade IV glioma that has come back.

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My recurrent tumor was confirmed by a biopsy before starting D2C7-IT treatment.

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My brain tumor has come back and is a grade IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have severe lung disease or my diabetes is not under control.

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I am not pregnant or breastfeeding.

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I haven't finished all standard treatments, including surgery and radiation.

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I do not have severe heart disease.

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I have taken more than 4 mg of dexamethasone daily in the last 2 weeks.

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I have an autoimmune disease but haven't needed systemic treatment for it in the last 3 months.

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I do not have an active infection needing IV treatment or a fever over 99.5°F.

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My cancer has spread to my brain or spinal cord and is actively growing.

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I have an immunosuppressive disease or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with an unacceptable adverse event

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 16Eligibility criteria met