Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

NCT03732768 | Completed Phase 1 DMC

• 2 other identifiers: RAD-18-0012018-002802-29
• Study Type: interventional
• Target: 21
• Locations: 3 countries
• Sites: 4

Brief Summary

RAD-18-001 is a First-In-Man, Dose Escalation study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first). In the expansion cohort the subject will receive the recommended dose. The expansion cohort will be conducted at 4 sites. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).

Conditions

Peritoneal Carcinomatosis; Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

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

  To investigate safety and toxicity of Radspherin®

  24 months

• Maximum Tolerated Dose (MTD)

  To determine the 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)

  21 days

Study Arms (1)

Radspherin

EXPERIMENTAL

Drug: Radspherin

Interventions

Radspherin DRUG

Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension. 224Ra has a physical half-life of 3.6 days. The Sponsor will provide Radspherin® in single dose glass vial and the dose for each subject will be prepared at the site.

Radspherin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender identity (Ovarian Cancer)
• 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 epithelial ovarian, fallopian tube and primary peritoneal carcinoma
• Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0.
• 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 10\^9/l

You may not qualify if:

• Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors)
• Tumors of borderline malignancy
• Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.
• Pregnant or lactating (nursing) women
• Active infections requiring antibiotics, and/or physician monitoring or recurrent fever \>38.0 ⁰C 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, prior to enrolment
• Concurrent administration of any cancer therapy other than planned study treatment 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
• Treatment with bevacizumab (Avastin®) within 5 weeks prior to CRS
• Known hypersensitivity to any of the excipients in the study drug
• Persons who have been placed in an institution under an official or judicial order

Sponsors & Collaborators

• Oncoinvent Solutions AS: lead

Study Sites (4)

UZ Leuven

Leuven, 3000, Belgium

Location

The Norwegian Radiumhospital

Oslo, Norway

Location

Clínica Universidad de Navarra

Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

Related Publications (1)

• Wang Y, Van Nieuwenhuysen E, Revheim ME, Deroose CM, Eriksson AGZ, Eyjolfsdottir B, Van Gorp T, Baert T, Aksnes AK, Myren K, Vergote I, Bruland OS. First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer. Gynecol Oncol. 2026 Jan;204:158-164. doi: 10.1016/j.ygyno.2025.11.018. Epub 2025 Dec 4.

  PMID: 41349345 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

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 study followed by an expansion cohort.

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: June 8, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ES (2); BE (1); NO (1)