D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

Conditions

• Newly Diagnosed MGMT Unmethylated Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• D2C7-IT — DRUG
  D2C7-IT will be dosed at 166,075 ng in 36 mL.
• 2141-V11 — DRUG
  2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.

Study Details

The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).

Key Dates

Start date

Sep 6, 2023

Status verified

Oct 2025

Primary completion

Oct 31, 2026

Completion

Oct 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: D2C7-IT + 2141-V11
  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.

Primary Outcome Measure

Median survival defined as the time between initiation of treatment with D2C7-IT in combination with 2141-V11 and death, or last follow up if alive. [ Time Frame: 3 years ]

Central Contacts

• Daniel Landi, MD
  919-684-5301
  [email protected]
• Stevie Threatt
  919-684-5301
  [email protected]

Locations (1)

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