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RECRUITING Phase 2

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 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Radspherin

Study Locations (10)

Other

  • UZ Leuven — Leuven
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
  • The Norwegian Radiumhospital — Oslo
  • Hospital Universitari de Bellvitge — Barcelona
  • Clinica Universidad de Navarra — Madrid
  • Clinica Universidad de Navarra — Pamplona
  • Hospital Universitari i Politècnic La Fe — Valencia
  • Imperial College Healthcare NHS Trust — London
  • University Hospital Southampton NHS Foundation Trust — Southampton

Florida

  • Moffitt Cancer Center — Tampa

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2024-06-15
Est. Completion 2031-02-28
Phase Phase 2

Sponsor

Oncoinvent Solutions AS

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06504147

The ClinicalTrials.gov registry entry for NCT06504147 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oncoinvent Solutions AS, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention — of which Radspherin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06504147 reports 10 study locations spanning 2 distinct geographic areas — top geographies include Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06504147 about?

NCT06504147 is a clinical study titled "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". 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,...

What is the current status of trial NCT06504147?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2024-06-15. Estimated completion is 2031-02-28.

What conditions does trial NCT06504147 study?

This clinical trial studies the following conditions: Ovarian Cancer, Peritoneal Carcinomatosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06504147?

The interventions under investigation include: Radspherin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06504147?

This trial is sponsored by Oncoinvent Solutions AS, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06504147 being conducted?

This trial has 10 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial