Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum

Phase 1 Terminated 54 enrolled Y-mAbs Therapeutics

NaSingle-groupOpen-labelTreatment

Summary

A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients \>1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum.

Timeline

Start: 2010-04
Primary completion: 2019-06-11
Completion: 2019-06-11

Outcome

Outcome not reported

Stopped (Business): “Corporate business decision. Not due to safety or efficacy concerns”

Publications

Modak S, Zanzonico P, Grkovski M, Slotkin EK, Carrasquillo JA, Lyashchenko SK, Lewis JS, Cheung IY, Heaton T, LaQuaglia MP, Cheung NV, Pandit-Taskar N. B7H3-Directed Intraperitoneal Radioimmunotherapy With Radioiodinated Omburtamab for Desmoplastic Small Round Cell Tumor and Other Peritoneal Tumors: Results of a Phase I Study. J Clin Oncol. 2020 Dec 20;38(36):4283-4291. doi: 10.1200/JCO.20.01974. Epub 2020 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omburtamab	Monoclonal antibody	1110 mbq	Other
Subject	Omburtamab	Monoclonal antibody	2960 mbq	Other
Subject	Omburtamab	Monoclonal antibody	3330 mbq	Other