Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC

Phase 1/2 Completed 47 enrolled Oncoinvent Solutions AS

NaSingle-groupOpen-labelPrevention

Summary

This is a phase 1/2a open label study to evaluate the dose, safety, tolerability and efficacy of an IP α-emitting radionuclide therapy (Radspherin®) in subjects with peritoneal carcinomatosis (PC) from colorectal carcinoma following complete CRS (cytoreduction score CC-0) and HIPEC. The study consists of three different cohorts: * Dose escalation cohorts * Repeated injection cohorts * Expansion cohort

Timeline

Start: 2020-05-27
Primary completion: 2025-05-14
Completion: 2025-05-14

Outcome

Met primary endpoint

release “The primary endpoint—peritoneal recurrence-free survival (pRFS)—yielded remarkable results: Only 27.8% (10 of 36) experienced peritoneal disease recurrence at 18 months” oncoinvent.com ↗

Publications

Larsen SG, Graf W, Mariathasan AB, Sorensen O, Spasojevic M, Goscinski MA, Selboe S, Lundstrom N, Holtermann A, Revheim ME, Bruland OS. First experience with 224Radium-labeled microparticles (Radspherin(R)) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study). Front Med (Lausanne). 2023 Mar 1;10:1070362. doi: 10.3389/fmed.2023.1070362. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Radspherin	Other / unclassified	1 mbq	Other
Subject	Radspherin	Other / unclassified	2 mbq	Other
Subject	Radspherin	Other / unclassified	4 mbq	Other
Subject	Radspherin	Other / unclassified	7 mbq	Other