NCT03732781

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

A Phase 1/2a Study to Evaluate the Dose, Safety and Tolerability and Efficacy of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Subjects With Peritoneal Carcinomatosis From Colorectal Carcinoma Following Hyperthermic Intraperitoneal Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Oncoinvent Solutions AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary objectives: * To investigate safety and toxicity of Radspherin® * To determine the maximum-tolerated dose (MTD) of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS) and hyperthermic IP chemotherapy (HIPEC) Secondary objectives: * To establish a recommended dose of Radspherin® as a single IP injection and two repeated IP injections following CRS and HIPEC * To describe the biodistribution of Radspherin® * To examine the efficacy and clinical benefit of Radspherin® following CRS and HIPEC Exploratory objectives: * To explore the association of biomarkers with activity/clinical benefits, adverse events (AEs), or other effects associated with Radspherin® * To explore effects of catheter placement, Radspherin® administration technique, and infusion volume on the distribution of 224Ra labelled micro particles in the peritoneal cavity The maximum number of subjects receiving Radspherin® in this study is 67. Subjects who discontinue prior to Radspherin® administration will be replaced. Dose escalation cohorts: 3 - 24 subjects Repeated injection cohorts: 3 subjects Expansion cohort: up to 40 subjects

Conditions

• Peritoneal Carcinoma
• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Radspherin	Radspherin® suspension consists of degradable calcium carbonate microparticles with the α-emitting radionuclide 224Ra in suspension. Radspherin® will be provided in a R10 vial filled with 10 mL suspension of 224Ra adsorbed on 1 g calcium carbonate microparticles. The volume to be administered will contain 0.7-1 g calcium carbonate microparticles with 1-7 MBq 224Ra. 224Ra has a half-life of 3.6 days.

Timeline

• Start date: 2020-05-27
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2018-11-07
• Last updated: 2025-08-28

Locations

2 sites across 2 countries: Norway, Sweden