NCT04396717

Safety Study of Pritumumab in Brain Cancer

Completed Phase 1 Last updated 6 December 2024

What this trial tests

Phase 1 trial testing Pritumumab in Malignant Primary Brain Tumors in 15 participants. Completed in 6 January 2023.

Timeline

22 February 2021

Primary endpoint
6 January 2023

6 January 2023

Quick facts

Lead sponsor	Nascent Biotech
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	22 February 2021
Primary completion	6 January 2023
Estimated completion	6 January 2023
Sites	2 locations across United States

Drugs / interventions tested

• Pritumumab — full drug profile →

Conditions studied

• Malignant Primary Brain Tumors — all drugs for Malignant Primary Brain Tumors →
• Brain Metastases, Adult — all drugs for Brain Metastases, Adult →

Sponsor

Nascent Biotech

Who can join

18 and older, any sex, with Malignant Primary Brain Tumors or Brain Metastases, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epithelial-mesenchymal transition: The history, regulatory mechanism, and cancer therapeutic opportunities.
   Huang Z, Zhang Z, Zhou C, Liu L, et al · · 2022 · cited 90× · PMID 35601657 · DOI 10.1002/mco2.144
2. COVID-19 update: The race to therapeutic development.
   Twomey JD, Luo S, Dean AQ, Bozza WP, et al · · 2020 · cited 50× · PMID 33161277 · DOI 10.1016/j.drup.2020.100733
3. Mechanisms of immune modulation in the tumor microenvironment and implications for targeted therapy.
   Czajka-Francuz P, Prendes MJ, Mankan A, Quintana Á, et al · · 2023 · cited 46× · PMID 37427115 · DOI 10.3389/fonc.2023.1200646
4. Pathophysiological Role of Vimentin Intermediate Filaments in Lung Diseases.
   Surolia R, Antony VB. · · 2022 · cited 14× · PMID 35573702 · DOI 10.3389/fcell.2022.872759
5. Advancements in precision nanomedicine design targeting the anoikis-platelet interface of circulating tumor cells.
   Tang M, Zhang Z, Wang P, Zhao F, et al · · 2024 · cited 12× · PMID 39220884 · DOI 10.1016/j.apsb.2024.04.034
6. A common goal to CARE: Cancer Advocates, Researchers, and Clinicians Explore current treatments and clinical trials for breast cancer brain metastases.
   Joe NS, Hodgdon C, Kraemer L, Redmond KJ, et al · · 2021 · cited 5× · PMID 34521857 · DOI 10.1038/s41523-021-00326-5
7. A phase 1 dose escalation of pritumumab in patients with refractory or recurrent gliomas or brain metastases.
   Carrillo J, Gill JM, Redfern C, Babic I, et al · · 2024 · cited 1× · PMID 39465217 · DOI 10.1093/noajnl/vdae166
8. Characterization of pritumumab in murine models and primate safety study.
   Mody AA, Mukthavaram R, Jiang P, Gangangari K, et al · · 2025 · PMID 40128557 · DOI 10.1038/s41598-025-95360-9