D2C7-IT + 2141-V11 for Glioblastoma

Phase 1 & 2

Recruiting

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for a type of brain tumor using drugs injected into the brain and under the skin.

Who is the study for?

Adults over 18 with newly diagnosed glioblastoma, a type of brain tumor, who've had surgery to remove it but still have some remaining disease. They must be in good health otherwise, with proper organ function and blood counts, not on high doses of steroids or anticoagulants that can't be paused for surgery. Participants should not be pregnant or breastfeeding and must agree to use birth control if they can have children.

What is being tested?

The trial is testing two investigational drugs: D2C7-IT given once inside the brain after surgery and 2141-V11 injected multiple times under the skin near lymph nodes. The study aims to see how safe these treatments are and how well they work against glioblastoma when combined with standard radiation therapy.

What are the potential side effects?

Potential side effects may include allergic reactions due to albumin content in drugs, liver issues leading to jaundice or coagulation problems, worsening muscle weakness from steroid treatment, immune system complications requiring recent immunomodulatory therapy, infections needing IV treatment, severe heart or lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: D2C7-IT + 2141-V11Experimental Treatment2 Interventions

Single D2C7-IT intratumoral infusion (6920 ng/mL in 36 mL) over 72 hours followed by single 2141-V11 infusion (5 dose levels) over 7 hours followed by an injection of 2141-V11 in the cervical perilymphatic subcutaneous area ipsilateral to the tumor at week 2, radiation, and further injections of 2141-V11 in the cervical perilymphatic subcutaneous area ipsilateral to the tumor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

D2C7-IT

2015

Completed Phase 1

~90

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