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

NCT03732781 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-08-28

No results posted yet for this study

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

Conditions

  • Peritoneal Carcinoma
  • Colorectal Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Oncoinvent AS

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732781 on ClinicalTrials.gov