NCT04608812

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection

Terminated Phase 1 Last updated 18 August 2023

What this trial tests

Phase 1 trial testing OS2966 in Glioma, Malignant in 7 participants. Terminated before completion.

Timeline

2 March 2021

Primary endpoint
27 February 2023

27 February 2023

Quick facts

Lead sponsor	OncoSynergy, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	2 March 2021
Primary completion	27 February 2023
Estimated completion	27 February 2023
Sites	1 location across United States

Drugs / interventions tested

• OS2966 — full drug profile →
• Gadoteridol (GADOTERIDOL) — full drug profile →

Conditions studied

• Glioma, Malignant — all drugs for Glioma, Malignant →
• High Grade Glioma — all drugs for High Grade Glioma →
• Glioblastoma — all drugs for Glioblastoma →
• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →

Sponsor

OncoSynergy, Inc. — full company profile →

Who can join

18 and older, any sex, with Glioma, Malignant or High Grade Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary goal of this Phase 1 study is to determine if a new investigational drug, OS2966, when delivered directly to the brain of adult participants with recurrent/progressive high-grade glioma (HGG) is safe and well tolerated.

OS2966 is a therapeutic antibody blocking a cell surface receptor governing fundamental biological processes that allow cancer cells to grow, spread and become resistant to cancer treatment. Despite availability of new promising cancer treatments, successful treatment of HGG has been limited by the presence of the brain's protective blood brain barrier (BBB). The BBB is made up of tightly knit cells that block entry of several substances including cancer treatments. To overcome this obstacle, a technique called convection-enhanced-delivery (CED) will be utilized to deliver OS2966 directly to the site of disease. Convection-enhanced delivery involves placement of one or more catheters into the brain tumor and tumor-infiltrated brain in order to slowly pump a therapy into the tissue.

To be eligible for this study participants must require surgical resection of their recurrent HGG.

Publications & conference data

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

1. Targeting integrin pathways: mechanisms and advances in therapy.
   Pang X, He X, Qiu Z, Zhang H, et al · · 2023 · cited 704× · PMID 36588107 · DOI 10.1038/s41392-022-01259-6
2. Emerging therapeutic opportunities for integrin inhibitors.
   Slack RJ, Macdonald SJF, Roper JA, Jenkins RG, et al · · 2022 · cited 394× · PMID 34535788 · DOI 10.1038/s41573-021-00284-4
3. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
4. Advances in local therapy for glioblastoma - taking the fight to the tumour.
   van Solinge TS, Nieland L, Chiocca EA, Broekman MLD. · · 2022 · cited 219× · PMID 35277681 · DOI 10.1038/s41582-022-00621-0
5. Targeting Integrins for Cancer Therapy - Disappointments and Opportunities.
   Bergonzini C, Kroese K, Zweemer AJM, Danen EHJ. · · 2022 · cited 93× · PMID 35356286 · DOI 10.3389/fcell.2022.863850
6. Translational landscape of glioblastoma immunotherapy for physicians: guiding clinical practice with basic scientific evidence.
   Kreatsoulas D, Bolyard C, Wu BX, Cam H, et al · · 2022 · cited 53× · PMID 35690784 · DOI 10.1186/s13045-022-01298-0
7. The characteristics and the multiple functions of integrin β1 in human cancers.
   Sun L, Guo S, Xie Y, Yao Y. · · 2023 · cited 52× · PMID 37932738 · DOI 10.1186/s12967-023-04696-1
8. Signaling pathways in brain tumors and therapeutic interventions.
   Li S, Wang C, Chen J, Lan Y, et al · · 2023 · cited 51× · PMID 36596785 · DOI 10.1038/s41392-022-01260-z