Actively Recruiting
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
Led by Oncoinvent Solutions AS · Updated on 2026-03-11
114
Participants Needed
10
Research Sites
349 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 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 to no residual tumor
- Adverse events from prior cancer therapy recovered to at least Grade 1 (excluding hair loss)
- Confirmed homologous recombination proficient by Myriad MyChoice CDx testing
- Received neoadjuvant chemotherapy with stable or regressing disease and operable to complete tumor removal
- ECOG Performance Status of 0 to 2 and fit for surgery and further treatment
- Adequate renal function with creatinine clearance ≥ 40 ml/min
- Adequate liver function with bilirubin < 1.5 x ULN and liver enzymes ≤ 3 x ULN
- Adequate bone marrow function with neutrophils ≥ 1.0 x 10^9/l, platelets ≥ 100 x 10^9/l, and hemoglobin ≥ 9 g/dL
- Negative pregnancy test for females of childbearing potential prior to enrollment
- Agreement to use highly effective contraception during treatment and for at least 9 months after if receiving Radspherin®, unless surgically sterile
You will not qualify if you...
- Known BRCA1 or BRCA2 mutations or homologous recombination deficiency
- Suspicion of peritoneal leak, shunt, or atypical pharmacokinetics
- Presence of epithelial borderline tumors, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumors, non-epithelial ovarian cancers, 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
- Pregnancy or lactation
- Active infections requiring antibiotics or recurrent fever > 38.0°C
- Active liver disease with positive hepatitis B or C, or HIV infection
- Congestive heart failure or history of advanced cardiac disease (NYHA class III/IV)
- Any condition compromising patient safety or study evaluation
- Inability to comply with study procedures or provide informed consent
- Recent investigational drug use within 4 weeks or 5 half-lives
- Concurrent cancer therapies other than study treatment within 4 weeks before and 4 weeks after surgery
- Treatment with bevacizumab within 5 weeks prior to surgery
- Known hypersensitivity to study drug excipients
AI-Screening
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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
CONTACT
T
Trine Jensen Gjertsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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