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Looking for participantsPhase2

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

Sponsor: Oncoinvent Solutions AS

NCT ID: NCT06504147

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Radspherin (drug)
How long the study runs
Study runs about 80 months (dates as stated)
About the drug or intervention
Radspherin — drug: Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension.
Patient visit burden
Not specified by the sponsor

In plain English

This study is looking at Radspherin® for women with advanced ovarian, fallopian tube, or primary peritoneal cancer that has spread to the lining of the abdomen (the peritoneum). It is for patients whose cancer is 'homologous recombination proficient', meaning a specific repair pathway in the cancer cells still works normally. Participants are due to have chemotherapy before surgery (called neoadjuvant chemotherapy) followed by an operation to remove the cancer (called interval debulking surgery).

Who can take part

  • Women aged 18 or over who can give written consent and follow the study plan
  • Diagnosis of advanced high-grade serous or high-grade endometrioid cancer of the ovary, fallopian tube, or peritoneum (FIGO stage IIIB/C or IV — FIGO is a system that describes how far the cancer has spread)
  • Cancer spread within the abdomen that the surgeon believes can be fully removed during the planned operation
  • Cancer confirmed as 'homologous recombination proficient' (HR proficient)
  • Already had chemotherapy before surgery, with scans showing the cancer has shrunk or stayed stable, and assessed as operable with no tumour left behind
  • Well enough for surgery and further treatment, with an ECOG performance status score of 0 to 2 (a measure of how well and active you are)
  • Healthy enough kidneys, liver, and blood counts, shown by blood tests
  • A negative pregnancy test before joining, for women who can still become pregnant, plus agreement to use highly effective contraception during treatment and for at least 9 months after receiving Radspherin® (unless the womb or ovaries are removed during surgery)

Who may not be able to

  • Known BRCA1 or BRCA2 gene changes (mutations), or cancer confirmed as 'homologous recombination deficient'
  • Possible leak or shunt in the abdomen, based on the doctor's judgement, your history, or scans
  • Certain other types of ovarian tumours, or cancer that has come back after earlier treatment
  • Cancer spread to the brain or spinal cord causing symptoms
  • Another cancer in the past 3 years, with a few exceptions such as some skin cancers
  • Previous radiotherapy to the abdomen or pelvis
  • Cancer that got worse during the chemotherapy given before surgery
  • Pregnancy or breastfeeding
  • Active infection needing antibiotics or monitoring, or a fever over 38°C with an infection
  • Active liver disease, or positive tests for hepatitis B, hepatitis C, or HIV
  • Serious heart failure now or in the past (NYHA class III/IV — a scale for heart failure severity)
  • Any other condition or illness that, in the study doctor's view, could affect your safety or the study results, or that would stop you following the study plan
  • Taking another experimental medicine recently (within 4 weeks or 5 times its half-life)
  • Having other cancer treatment within 4 weeks before or up to 4 weeks after the surgery
  • Treatment with a medicine called bevacizumab within 5 weeks before the surgery
  • Known severe allergy to any of the other ingredients in the study drug

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team. Taking part involves receiving Radspherin® around planned chemotherapy and surgery, using effective contraception for at least 9 months afterwards if applicable, and following the study plan.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
114
Started
2024-06-15
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for peritoneal carcinomatosis
  • • Phase2 - 114 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with peritoneal carcinomatosis
  • • Female only

Where?

  • • London - Imperial College Healthcare NHS Trust
  • • Southampton - University Hospital Southampton NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Peritoneal CarcinomatosisOvarian Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

BRCA1BRCA2with positive

What the study is looking for

  • ✓Able and willing to provide written agreement to take part 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...
  • ✓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...

Who cannot take part

  • ✗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...
  • ✗causing symptoms central nervous system metastasis.
  • ✗Prior abdominal/pelvic radiotherapy.
  • ✗Disease progression during NACT.
See the full criteria
Inclusion Criteria: 1. Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP). 2. Female of age ≥ 18 years. 3. 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). 4. Peritoneal and other metastases eligible for IDS to no residual tumour. 5. Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy. 6. Confirmed HR proficient tumour. 7. 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. 8. 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. 9. Adequate renal function: • Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min. 10. Adequate hepatic function: * Serum bilirubin \< 1.5 x upper limit of normal (ULN), and * Aspartate transaminase and alanine transaminase ≤ 3 x ULN. 11. Adequate bone marrow function: * Absolute neutrophil count ≥ 1.0 x 10\^9/l, and * Platelets ≥ 100 x 10\^9/l, and * Haemoglobin ≥ 9 g/dL. 12. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment. 13. For females of childbearing potential agreement to use at least one of the following highly effective (failure rate \< 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®, unless hysterectomy or oophorectomy is performed during IDS. * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. * Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Note: In addition to the use of one highly effective method of contraception as listed above, a condom is required for all male partners during the treatment period and for at least 9 months after the dose of IMP, unless vasectomised at least 6 months prior to enrolment. Exclusion Criteria: 1. Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient. 2. Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images. 3. 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. 4. Symptomatic central nervous system metastasis. 5. 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). 6. Prior abdominal/pelvic radiotherapy. 7. Disease progression during NACT. 8. Pregnant or lactating (nursing) women. 9. Active infections requiring antibiotics, and/or physician monitoring, or recurrent fever \> 38.0⁰C associated with a clinical diagnosis of active infection. 10. Active liver disease with positive serology for active hepatitis B, hepatitis C or known human immunodeficiency virus (HIV). 11. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease. 12. 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. 13. 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. 14. Administration of an investigational medicinal product within 4 weeks, or at least 5 times the half life, prior to enrolment. 15. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the surgery. 16. Treatment with bevacizumab within 5 weeks prior to IDS. 17. Known hypersensitivity to any of the excipients of the study drug.

Where Is This Study? (2 UK sites)

Imperial College Healthcare NHS Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Anne-Kirsti Aksnes, PhD

Sponsor contact

CONTACT

004722183305 aksnes@oncoinvent.com

Trine Jensen Gjertsen

Sponsor contact

CONTACT

004722183305 gjertsen@oncoinvent.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05