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Safety Study of Pritumumab in Brain Cancer

NCT04396717 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-12-06

No results posted yet for this study

Summary

Pritumumab is a human IgG1 kappa antibody that binds to a malignant tumor associated antigen, ecto domain-vimentin (EDV) which is expressed in a variety of tumor cells. Pritumumab was shown to have relatively high reactivity with brain cancer cell lines, while no reactivity was demonstrated with normal neurons, astrocytes or fetal cerebral cells. Pritumumab has notable antibody-dependent cellular cytotoxicity (ADCC), brain tumor penetration and antitumor activity in nude mouse human xenograft models.

Primary Objectives

\- To determine the safety and/or tolerability and the recommended Phase 2 dose (RP2D) of escalating, intravenously (IV) administered Pritumumab doses in patients with recurrent gliomas or with brain metastases.

Secondary Objectives

* To determine pharmacokinetics and pharmacodynamics of Pritumumab
* To identify preliminary signals of anti-tumor response to Pritumumab
* To explore disease-related, patient-reported outcomes

Conditions

  • Malignant Primary Brain Tumors
  • Brain Metastases, Adult

Interventions

BIOLOGICAL

Pritumumab

Pritumumab IgG1 human monoclonal antibody

Sponsors & Collaborators

  • Hoag Memorial Hospital Presbyterian

    collaborator OTHER

  • Nascent Biotech

    lead INDUSTRY

Principal Investigators

  • Jose A. Carrillo, MD · One Hoag Drive Newport Beach, CA 92663, United States

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2023-01-06
Completion
2023-01-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396717 on ClinicalTrials.gov