Radspherin for Ovarian Cancer

Recruiting at 5 trial locations

Overseen By Trine Jensen Gjertsen

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Oncoinvent AS

Must be taking: NACT

Must not be taking: Bevacizumab

Disqualifiers: BRCA mutations, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Radspherin for certain types of advanced ovarian cancer. It targets women with a specific kind of ovarian cancer that has spread to the abdominal lining and who plan to undergo surgery to remove the tumor. Participants must have shown some improvement or stable disease after initial chemotherapy and be healthy enough for further treatment. The main goal is to determine if a single injection of Radspherin, an alpha-emitting radionuclide therapy, is safe and more effective against cancer than standard care alone. Those without a genetic mutation related to the cancer (such as BRCA) and no signs of another active cancer may be eligible. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take any other cancer therapy within 4 weeks before and after the surgery, and you must not have taken bevacizumab within 5 weeks prior to the surgery.

Is there any evidence suggesting that Radspherin is likely to be safe for humans?

Research has shown that Radspherin has promising safety results from earlier studies. In a previous study, patients who received Radspherin tolerated it well. This treatment uses targeted radiation to attack cancer cells in the abdomen.

That study reported no major safety issues. Some patients experienced mild side effects, but these were short-lived and manageable. This suggests that most patients could tolerate the treatment well.

It's important to remember that this information comes from a study focused on safety. The current trial will provide more insights into both safety and effectiveness. Prospective participants might find reassurance in these previous findings regarding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Radspherin is unique because it uses targeted alpha therapy, which is a novel approach for treating ovarian cancer. Unlike traditional chemotherapy that attacks both cancerous and healthy cells, Radspherin delivers high-energy alpha particles directly to the cancer cells, potentially minimizing damage to surrounding healthy tissues. Researchers are excited about Radspherin because this precision not only promises to be more effective but also aims to reduce the side effects commonly associated with existing treatments.

What evidence suggests that Radspherin might be an effective treatment for ovarian cancer?

Research has shown that Radspherin, which participants in this trial may receive, could be promising for treating ovarian cancer. In earlier studies, Radspherin used inside the abdominal cavity demonstrated a strong ability to target and treat small cancer spreads in ovarian cancer. Early trial results also emphasize its ongoing potential and effectiveness. Radspherin delivers targeted radiation, effectively treating cancer cells in body cavities. This makes it a hopeful option for patients with ovarian cancer that has spread within the abdominal area. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer that has spread to the lining of the abdomen and are able to undergo chemotherapy and surgery. Participants must have a specific type of tumor (high-grade serous or endometrioid) that repairs DNA normally (HR proficient).

Inclusion Criteria

Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP)

I've finished 3 or 4 rounds of chemo with no cancer growth and can have surgery to remove all cancer.

I am a woman aged 18 or older.

Exclusion Criteria

My cancer got worse during the first 3-4 rounds of chemotherapy.

I have had radiotherapy to my abdomen or pelvis before.

I do not have active liver disease or a positive test for hepatitis B, C, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

A Safety Lead-in Cohort will be recruited to evaluate the safety of the treatment

4-6 weeks

Treatment

Participants receive a single intraperitoneal injection of Radspherin® and undergo NACT and IDS

6-8 weeks

Follow-up

Participants are monitored for progression-free survival and peritoneal progression-free survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Radspherin

Trial Overview The study tests Radspherin®, given as a single injection into the abdomen, in two parts: first assessing safety in a small group, then randomly assigning participants to receive Radspherin® or not alongside standard treatment. All patients will have chemotherapy and surgery aimed at removing all visible tumor.

How Is the Trial Designed?

Group I: Radspherin Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Radspherin is already approved in United States for the following indications:

Approved in United States as Radspherin for:

• Peritoneal metastases from ovarian cancer (Fast Track Designation)

Who Is Running the Clinical Trial?

Oncoinvent AS

Lead Sponsor

Trials

3

Recruited

230+

Published Research Related to This Trial

The novel treatment using 224Ra-labeled calcium carbonate microparticles (224Ra-CaCO3-MP) showed a slight therapeutic benefit in extending survival in a mouse model of ovarian cancer, with median survival ratios ranging from 1.1 to 1.3 compared to control.

When combined with standard chemotherapy regimens like carboplatin-paclitaxel or carboplatin-pegylated liposomal doxorubicin, 224Ra-CaCO3-MP demonstrated a synergistic effect on overall survival, indicating its potential as an effective treatment option for micrometastatic peritoneal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal alpha therapy with 224Ra-labeled microparticles combined with chemotherapy in an ovarian cancer mouse model. Wouters, R., Westrøm, S., Berckmans, Y., et al.[2022]

The study of six colorectal cancer patients receiving radium-224 adsorbed to calcium carbonate micro particles (224Ra-CaCO3-MP) showed a median effective whole-body half-life of approximately 3 days, indicating a manageable duration of radiation exposure post-treatment.

Hospital workers can safely care for 200-400 patients treated with 224Ra-CaCO3-MP annually without exceeding the effective dose limit of 6 mSv, while family members and the public are expected to receive minimal exposure (below 0.25 mSv), suggesting no need for additional safety restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation safety considerations for the use of radium-224-calciumcarbonate-microparticles in patients with peritoneal metastasis. Grønningsæter, SR., Blakkisrud, J., Selboe, S., et al.[2023]

Calcium carbonate microparticles can effectively carry radium-224 for targeted internal therapy in treating micrometastatic cancers, particularly in the peritoneal cavity, showing over 95% retention of radioactivity for up to a week in vitro.

The study demonstrated that the distribution of radium-224 in the body is influenced by the amount of microparticles administered, suggesting that these microparticles can minimize unwanted skeletal uptake while delivering localized treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ra-224 labeling of calcium carbonate microparticles for internal α-therapy: Preparation, stability, and biodistribution in mice. Westrøm, S., Malenge, M., Jorstad, IS., et al.[2021]

Radium-224-labeled CaCO3 microparticles have shown significant antitumor effects in treating advanced-stage ovarian cancer in a mouse model, demonstrating improved survival rates with lower doses compared to cationic 224Ra in solution.

The most effective treatment was achieved with microparticles at higher specific activities (2.6 and 4.6 kBq/mg), indicating that optimizing the ratio of activity to mass can enhance therapeutic outcomes in targeting peritoneal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium Carbonate Microparticles as Carriers of 224Ra: Impact of Specific Activity in Mice with Intraperitoneal Ovarian Cancer. Li, RG., Napoli, E., Jorstad, IS., et al.[2021]

Radium-224 (224Ra) labeled calcium carbonate (CaCO3) microparticles show promise as a localized cancer therapy, particularly for micrometastatic disease, by effectively delivering alpha-particle radiation.

The study found that 220Rn diffusion is reduced in these microparticles compared to cationic solutions, and over 70% of the longer-lived lead-212 (212Pb) can be re-adsorbed onto the microparticles, potentially enhancing therapeutic efficacy in the peritoneal cavity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radon-220 diffusion from 224Ra-labeled calcium carbonate microparticles: Some implications for radiotherapeutic use. Napoli, E., Bønsdorff, TB., Jorstad, IS., et al.[2021]

Radspherin®, a novel treatment using radium-224, was well tolerated in a phase 1 study with 23 patients, showing no dose-limiting toxicities and no serious adverse events directly related to the treatment.

The study demonstrated that Radspherin® effectively distributes evenly in the peritoneal cavity, suggesting its potential to target residual cancer cells after surgery and chemotherapy for colorectal cancer with peritoneal metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experience with 224Radium-labeled microparticles (Radspherin®) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study). Larsen, SG., Graf, W., Mariathasan, AB., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5789152/

Therapeutic Effect of α-Emitting 224Ra-Labeled Calcium ... Intraperitoneal α-therapy with 224 Ra-microparticles demonstrated a significant potential for treatment of peritoneal micrometastases in ovarian carcinoma.

2. oncoinvent.com oncoinvent.com/press-release/oncoinvent-reports-positive-final-data-from-phase-1-trial-of-radspherin-to-treat-ovarian-cancer/

Oncoinvent Reports Positive Final Data from Phase 1 Trial ... Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin® to Treat Ovarian Cancer. New Data Highlight Continued Potential of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06504147

NCT06504147 | A Study of Radspherin® in Patients with ... This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/oncoinvent-ovarian-cancer-trial/

Oncoinvent doses first subject in Phase II ovarian cancer trial Oncoinvent has dosed the first subject in Phase II trial of Radspherin to treat peritoneal carcinomatosis originating from ovarian cancer.

5. openmedscience.com openmedscience.com/radium-224-radspherin-a-groundbreaking-approach-to-targeting-metastatic-cancer-in-body-cavities/

Radium-224 RadSpherin for Metastatic Cancer Radium-224 RadSpherin delivers targeted alpha radiation therapy to treat metastatic cancers within body cavities effectively.