Spots Global Cancer Trial Database for Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC

Study Description

Brief 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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