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ACTIVE_NOT_RECRUITINGPHASE1

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

A Phase 1 Study to Evaluate the Dose, Safety and Tolerability of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis Following CRS

NCT03732768•Oncoinvent Solutions AS

View on ClinicalTrials.gov

Summary

RAD-18-001 is a First-In-Man, Dose Escalation study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first). In the expansion cohort the subject will receive the recommended dose. The expansion cohort will be conducted at 4 sites. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).

Detailed Description

The maximum number of subjects enrolled in this study is 49. The following number of subjects will be recruited in the different cohorts: * Dose escalation cohorts: 3 - 24 Subjects * Expansion cohort: Up to 25 Subjects

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Able and willing to provide written informed consent and to comply with the clinical study protocol
•2. Age ≥ 18 years
•3. Histologically confirmed epithelial ovarian, fallopian tube and primary peritoneal carcinoma
•4. Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0.
•5. AEs recovered to at least grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy at time of first administration of Radspherin®
•6. ECOG Performance Status Score of 0 - 1
•7. Adequate renal function
•* Creatinine ≤ 1.8 mg/dl (159 μmol/l) and
•* calculated creatinine clearance using the Cockcroft-Gault formula ≥ 45 ml/min, or
•* measured creatinine clearance ≥ 45 ml/min
+10 more criteria

Exclusion Criteria

•1. Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors)
•2. Tumors of borderline malignancy
•3. Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.
•4. Pregnant or lactating (nursing) women
•5. Active infections requiring antibiotics, and/or physician monitoring or recurrent fever \>38.0 ⁰C associated with a clinical diagnosis of active infection
•6. Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV
•7. Administration of an investigational medicinal product within 28 days, or at least 5 times the half-life, prior to enrolment
•8. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the last study treatment
•9. Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)
•10. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
+7 more criteria

Locations (4)

UZ Leuven

Leuven, Belgium

The Norwegian Radiumhospital

Oslo, Norway

Clínica Universidad de Navarra

Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Spain

Key Dates

Start Date

June 8, 2020

Primary Completion Date

August 1, 2025

Completion Date

August 1, 2025

Last Updated

August 22, 2025

Enrollment

ESTIMATED participants

Conditions

Peritoneal CarcinomatosisOvarian Cancer

Interventions

Radspherin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

Inclusion Criteria

Exclusion Criteria

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