Peritoneal CarcinomatosisPhase 1NCT03732768
Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis
A Phase 1 study testing Radspherin in people with Peritoneal Carcinomatosis and Ovarian Cancer, run by Oncoinvent Solutions AS at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peritoneal Carcinomatosis, Ovarian Cancer
- What is being tested?
- Radspherin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 8 Jun 2020to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent and to comply with the clinical study protocol
- Age ≥ 18 years
- Histologically confirmed epithelial ovarian, fallopian tube and primary peritoneal carcinoma
- Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0.
- 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®
- ECOG Performance Status Score of 0 - 1
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- 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
- Adequate hepatic function
- Serum bilirubin <1.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l
- Platelets ≥ 100 x 10^9/l
- Haemoglobin ≥ 9 g/dL
- Adequate coagulation tests: INR ≤ 1.5 x ULN
- For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment
- For females of childbearing potential who have a male partner: agreement to use two adequate methods of contraception (e.g. barrier, intrauterine device, hormonal implants, combined oral contraceptives or vasectomized partner), during the treatment period and for at least 3 months after the last dose of IMP.
Who cannot join
- Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors)
- Tumors of borderline malignancy
- Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.
- Pregnant or lactating (nursing) women
- Active infections requiring antibiotics, and/or physician monitoring or recurrent fever >38.0 ⁰C associated with a clinical diagnosis of active infection
- Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV
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- Administration of an investigational medicinal product within 28 days, or at least 5 times the half-life, prior to enrolment
- 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
- 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)
- Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
- Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise the safety of the subjects or interfere with the evaluation of the safety of the IMP
- In the Investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent
- Treatment with bevacizumab (Avastin®) within 5 weeks prior to CRS
- Known hypersensitivity to any of the excipients in the study drug
- Persons who have been placed in an institution under an official or judicial order
- Persons who are dependent on the sponsor financially must be excluded from participation
- Persons with active SARS-CoV-2 infection must be excluded from participation
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Clínica Universidad de Navarra
Madrid
Clínica Universidad de Navarra
Pamplona
About this study
Official title: 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
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).
Read the 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
- Conditions
- Peritoneal Carcinomatosis, Ovarian Cancer
- Being tested
- Radspherin
- Medical subject headings
- Peritoneal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadspherinDrug
Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension. 224Ra has a physical half-life of 3.6 days. The Sponsor will provide Radspherin® in single dose glass vial and the dose for each subject will be prepared at the site.
| Study group | Role | What they receive |
|---|---|---|
| Radspherin | Experimental | Not described Receives: Drug: Radspherin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0.
To investigate safety and toxicity of Radspherin®
Measured: 24 months
Maximum Tolerated Dose (MTD)
To determine the MTD of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start8 Jun 2020
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3+3 dose escalation study followed by an expansion cohort.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncoinvent Solutions AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732768
- Sponsor's protocol ID
- RAD-18-001
- Other IDs
- 2018-002802-29, 2018
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2018
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Y, Van Nieuwenhuysen E, Revheim ME, Deroose CM, Eriksson AGZ, Eyjolfsdottir B, Van Gorp T, Baert T, Aksnes AK, Myren K, Vergote I, Bruland OS. First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer. Gynecol Oncol. 2026 Jan;204:158-164. doi: 10.1016/j.ygyno.2025.11.018. Epub 2025 Dec 4.
PubMed 41349345
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03732768
- Acronym / sponsor ID
- RAD-18-001
- Conditions
- Peritoneal Carcinomatosis, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Oncoinvent Solutions ASIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose escalation study followed by an expansion cohort.
| Arm | Type | Receives |
|---|---|---|
| Radspherin | Experimental | Drug: Radspherin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Able and willing to provide written informed consent and to comply with the clinical study protocol
- Age ≥ 18 years
- Histologically confirmed epithelial ovarian, fallopian tube and primary peritoneal carcinoma
- Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0.
- 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®
Key exclusion criteria (17 listed)
- Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors)
- Tumors of borderline malignancy
- Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.
- Pregnant or lactating (nursing) women
- Active infections requiring antibiotics, and/or physician monitoring or recurrent fever >38.0 ⁰C associated with a clinical diagnosis of active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadspherinRadspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension. 224Ra has a physical half-life of 3.6 days. The Sponsor will provide Radspherin® in single dose glass vial and the dose for each subject will be prepared at the site. | Drug | Radspherin |
Primary outcome
Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0.
Time frame: 24 months
To investigate safety and toxicity of Radspherin®
Maximum Tolerated Dose (MTD)
Time frame: 21 days
To determine the MTD of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 41349345Wang Y, Van Nieuwenhuysen E, Revheim ME, Deroose CM, Eriksson AGZ, Eyjolfsdottir B, Van Gorp T, Baert T, Aksnes AK, Myren K, Vergote I, Bruland OS. First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer. Gynecol Oncol. 2026 Jan;204:158-164. doi: 10.1016/j.ygyno.2025.11.018. Epub 2025 Dec 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radspherin in people with Peritoneal Carcinomatosis and Ovarian Cancer, run by Oncoinvent Solutions AS at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Belgium, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.