Actively Recruiting
A Phase 2 Open Label Study of Intraperitoneal Alpha-emitting Radionuclide Therapy Radspherin in Patients With Primary Advanced High-grade Serous or Endometrioid Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Scheduled for Neoadjuvant Chemotherapy and Interval Debulking Surgery
Led by Oncoinvent Solutions AS · Updated on 2026-05-20
114
Participants Needed
10
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a single intraperitoneal injection of Radspherin4 in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer that has spread within the peritoneal cavity. This Phase 2, randomized, open-label, multicenter study focuses on patients whose tumors are homologous recombination proficient and who are scheduled for neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) aiming to remove all visible tumors (R0 resection). The study includes a safety lead-in phase followed by a randomized treatment phase, with the same procedures and assessments for all participants. Participants will receive either Radspherin, which is a suspension of biodegradable calcium carbonate microparticles containing the alpha-emitting radionuclide 224Ra, or no additional intervention in the control group. The radionuclide has a physical half-life of 3.6 days. Both groups will undergo NACT and IDS as planned. The study is divided into two parts: an initial safety lead-in cohort, then a randomized phase comparing Radspherin versus control. Throughout the study, participants will be monitored for progression-free survival up to 24 months as the primary outcome. Additional assessments will include peritoneal progression-free survival and safety evaluations. Patients will have regular clinical assessments, imaging, and laboratory tests to evaluate disease status and treatment effects. The study will continue until February 2031, with ongoing follow-up to track outcomes and safety.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with the clinical study protocol.
- Female aged 18 years or older.
- Diagnosed 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 interval debulking surgery aiming for no residual tumor.
- Recovered from prior medical therapy adverse events to at least Grade 1 (excluding hair loss).
- Confirmed homologous recombination proficient tumor.
- Received neoadjuvant chemotherapy with tumor regression or stable disease on imaging and assessed as operable to complete resection.
- Eastern Cooperative Oncology Group Performance Status score of 0 to 2 and fit for surgery and further treatment.
- Adequate renal function (creatinine clearance 240 ml/min).
- Adequate liver function (bilirubin <1.5 times upper limit of normal; AST and ALT 2 3 times upper limit of normal).
- Adequate bone marrow function (neutrophil count 21.0 x 10^9/l; platelets 2 100 x 10^9/l; hemoglobin 2 9 g/dL).
- Negative pregnancy test for females of childbearing potential.
- Use of highly effective contraception during treatment and for at least 9 months after Radspherin unless sterilized or surgically sterilized as specified.
- Male partners must use condoms during treatment and for at least 9 months after dosing unless vasectomized at least 6 months prior.
You will not qualify if you...
- Known BRCA1 or BRCA2 mutations or homologous recombination deficient tumors.
- Suspicion of peritoneal leak, shunt, or atypical drug distribution.
- Presence of epithelial borderline tumors, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumors, non-epithelial ovarian malignancies, carcinosarcoma, neuroendocrine tumors, or recurrent ovarian cancer.
- Symptomatic central nervous system metastases.
- Another primary cancer within the past 3 years except certain early-stage skin or cervical cancers.
- Prior abdominal or pelvic radiotherapy.
- Disease progression during neoadjuvant chemotherapy.
- Pregnant or breastfeeding women.
- Active infections requiring antibiotics or physician monitoring, or recurrent fever above 38.0 degrees Celsius.
- Active liver disease with hepatitis B, hepatitis C, or HIV infection.
- Congestive heart failure or history of severe cardiac disease (NYHA class III/IV).
- Any condition that compromises safety or study evaluation as judged by investigators.
- Inability to comply with study procedures or give informed consent.
- Recent investigational drug use within 4 weeks or 5 times the half-life before enrollment.
- Cancer treatments other than planned study treatment within 4 weeks before and 4 weeks after surgery.
- Treatment with bevacizumab within 5 weeks prior to surgery.
- Known allergy to any components of the study drug.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration prior to surgery
Participants receive chemotherapy before surgery to reduce tumor size.
Visit schedule as per chemotherapy regimen
Duration - Surgery and immediate treatment period
Participants undergo surgery to remove tumors followed by treatment with Radspherin® alpha-emitting radionuclide therapy.
1 hospital stay including surgery and Radspherin administration
Duration - Up to 24 months
Participants are monitored after surgery and treatment for recovery and safety.
Regular follow-up visits during this period
Trial Site Locations
Total: 10 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
UZ Leuven
Leuven, Belgium
Actively Recruiting
3
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Actively Recruiting
4
The Norwegian Radiumhospital
Oslo, Norway
Actively Recruiting
5
Hospital Universitari de Bellvitge
Barcelona, Spain
Actively Recruiting
6
Clinica Universidad de Navarra
Madrid, Spain
Actively Recruiting
7
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
8
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Actively Recruiting
9
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
10
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
Research Team
A
Anne-Kirsti Aksnes, PhD
T
Trine Jensen Gjertsen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here