A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

NCT06504147 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RAD-18-003
• Study Type: interventional
• Target: 114
• Locations: 6 countries
• Sites: 10

Brief Summary

This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.

Conditions

Peritoneal Carcinomatosis; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  To compare PFS in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer1 with peritoneal metastasis that are HR proficient following Radspherin® treatment versus no treatment.

  24 months

Secondary Outcomes (1)

• Peritoneal progression free survival

  24 months

Study Arms (2)

Radspherin

EXPERIMENTAL

Drug: Radspherin

Control

NO INTERVENTION

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.

Radspherin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• 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 (CSP).
• Female of age ≥ 18 years.
• Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C or IV).
• Peritoneal and other metastases eligible for IDS to no residual tumour.
• Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.
• Confirmed HR proficient by Myriad MyChoice CDx testing.
• Received NACT (numbers of cycles as per investigator's discretion) with regress or stable disease on diagnostic imaging and assessed to be operable to R0 pre-surgery.
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 2 and patient fit enough to undergo IDS and further treatment according to standard of care.
• Adequate renal function:
• Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min.
• Adequate hepatic function:
• Serum bilirubin \< 1.5 x upper limit of normal (ULN), and
• Aspartate transaminase and alanine transaminase ≤ 3 x ULN.
• Adequate bone marrow function:
• Absolute neutrophil count ≥ 1.0 x 10\^9/l, and

You may not qualify if:

• Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
• Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images.
• Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumours, non-epithelial ovarian malignancies, carcinosarcoma and neuroendocrine tumours or recurrent ovarian cancer.
• Symptomatic central nervous system metastasis.
• Another primary malignancy within the past 3 years (except for non melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ or FIGO 2023 Stage IA1 or IA3 prior or synchronous endometrial cancer).
• Prior abdominal/pelvic radiotherapy.
• Disease progression during NACT.
• 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 human immunodeficiency virus (HIV).
• 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 patients or interfere with the evaluation of the safety of the investigational medicinal product.
• 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.
• Administration of an investigational medicinal product within 4 weeks, 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 surgery.

Sponsors & Collaborators

• Oncoinvent Solutions AS: lead

Study Sites (10)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

RECRUITING

The Norwegian Radiumhospital

Oslo, Norway

RECRUITING

Hospital Universitari de Bellvitge

Barcelona, Spain

RECRUITING

Clinica Universidad de Navarra

Madrid, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Spain

RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

RECRUITING

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

Central Study Contacts

Anne-Kirsti Aksnes, PhD

CONTACT

004722183305; aksnes@oncoinvent.com

Trine Jensen Gjertsen

CONTACT

004722183305; gjertsen@oncoinvent.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 28, 2031
• Last Updated: March 11, 2026

Record last verified: 2026-01

Locations

IT (1); US (1); GB (2); BE (1); NO (1); ES (4)