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

NCT03732781 | Completed Phase 1 DMC

• 2 other identifiers: RAD-18-0022018-002803-33
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 2

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

Conditions

Peritoneal Carcinoma; Colorectal Carcinoma

Outcome Measures

Primary Outcomes (3)

• Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0.

  To investigate safety and toxicity of Radspherin®

  18 months

• Maximum Tolerated Dose

  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)

  21 Days

• Explore efficacy (expansion cohort)

  Peritoneal recurrence free survival

  18 months

Study Arms (1)

Radspherin

EXPERIMENTAL

Drug: Radspherin

Interventions

Radspherin DRUG

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.

Radspherin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the clinical study protocol
• Age ≥ 18 years
• Histologically confirmed colorectal carcinoma
• Peritoneal metastases (PCI≤20 assessed during surgery), and histologically confirmed as peritoneal carcinomatosis) eligible for cytoreductive surgery and HIPEC treatment that reaches CC-0 at the end of the surgical procedure
• AEs recovered to at least grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy at time of first administration of Radspherin®
• ECOG Performance Status Score of 0 - 1
• Adequate renal function
• Creatinine ≤ 1.8 mg/dl (159 μmol/l) and
• Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 45 ml/min, or
• Measured creatinine clearance ≥ 45 ml/min
• Adequate hepatic function
• Serum bilirubin \<1.5 x upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/l

You may not qualify if:

• Peritoneal metastasis originating from appendix vermiformis. Other synchronous visceral metastatic lesions in liver or lungs, symptomatic central nervous system (CNS) metastases. Metastatic lymph nodes or thoracic lymph nodes
• Resection or suture of the diaphragm (assessed during surgery)
• Pregnant or lactating (nursing) women
• Active infections requiring antibiotics and/or physician monitoring, or recurrent fever \>38.0⁰C associated with a clinical diagnosis of active infection
• Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV
• Administration of an investigational medicinal product within 28 days or at least 5 times the half-life
• Concurrent administration of any other cancer therapy other within 4 weeks prior to, and up to 4 weeks after the last study treatment
• Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)
• Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
• Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise the safety of the subjects or interfere with the evaluation of the safety of the IMP
• In the Investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent
• Known hypersensitivity to any of the excipients in the study drug

Sponsors & Collaborators

• Oncoinvent AS: lead

Study Sites (2)

Oslo University Hospital

Oslo, Norway

Location

Akademiska

Uppsala, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36936230 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 Dose escalation with expansion cohort

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: May 27, 2020
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

SE (1); NO (1)