OncoMatch/Clinical Trials/NCT06504147
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
Is NCT06504147 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Radspherin for peritoneal carcinomatosis.
Treatment: Radspherin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Excluded: BRCA1 mutation
Known somatic or germline BRCA1 or BRCA2 mutations
Excluded: BRCA2 mutation
Known somatic or germline BRCA1 or BRCA2 mutations
Disease stage
Required: Stage FIGO STAGE IIIB, FIGO STAGE IIIC, FIGO STAGE IV (FIGO)
Metastatic disease required
Grade: high-grade
FIGO Stage IIIB/C or IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
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
Cannot have received: abdominal/pelvic radiotherapy
Prior abdominal/pelvic radiotherapy
Cannot have received: bevacizumab (bevacizumab)
Treatment with bevacizumab within 5 weeks prior to IDS
Cannot have received: investigational medicinal product
Administration of an investigational medicinal product within 4 weeks, or at least 5 times the half life, prior to enrolment
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.0 x 10^9/l, platelets ≥ 100 x 10^9/l, haemoglobin ≥ 9 g/dL
Kidney function
Calculated creatinine clearance using Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min
Liver function
Serum bilirubin < 1.5 x ULN, AST and ALT ≤ 3 x ULN
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 ULN, AST and ALT ≤ 3 x ULN. Adequate bone marrow function: Absolute neutrophil count ≥ 1.0 x 10^9/l, platelets ≥ 100 x 10^9/l, haemoglobin ≥ 9 g/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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