Porphysome Nanoparticles for Gynecological Cancers

Overseen By Stephanie Lheureux, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University Health Network, Toronto

Must not be taking: Radiopharmaceuticals

Disqualifiers: Myelodysplastic syndrome, Leukemia, Porphyria, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using porphysome nanoparticles, a type of imaging agent, to enhance imaging for advanced gynecological cancers. The goal is to evaluate the effectiveness of these nanoparticles when combined with PET/CT scans to improve images of tumors that have spread. Women diagnosed with metastatic gynecological cancer who are still receiving standard treatments may qualify. Participants must be able to undergo PET/CT scans and adhere to the study's schedule. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial requires that you stop any other cancer treatments, like chemotherapy or radiation, at least 2 weeks before starting the study drug and for 28 days after. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Porphysome Nanoparticles are under study for their safety and effects in treating advanced gynecological cancers. Currently, researchers are testing these nanoparticles to determine their ability to target and image tumors. As this research is in its early stages, the primary goal is to assess the treatment's safety for humans.

Since this is the first human trial of this treatment, the study closely monitors for any side effects or adverse reactions. Safety information is still being gathered, and not all possible side effects are known. However, early studies are crucial to determine if a new treatment is safe. If proven safe, it could offer a new method to detect and potentially treat gynecological cancers in the future. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about porphysome nanoparticles because they offer a unique approach to treating gynecological cancers. Unlike traditional treatments, such as surgery, chemotherapy, and radiation, which can affect both cancerous and healthy cells, porphysomes are designed to specifically target cancer cells. These nanoparticles utilize a novel mechanism where they accumulate in tumors and can be activated by light or radiofrequency to destroy cancer cells selectively. This targeted action not only has the potential to improve treatment effectiveness but also reduces the likelihood of damaging healthy tissues, potentially leading to fewer side effects.

What evidence suggests that Porphysome Nanoparticles might be an effective treatment for gynecological cancers?

Research has shown that Porphysome nanoparticles could enhance the visibility of gynecological cancers in scans. These tiny particles help doctors obtain a clearer view of tumors. Studies have found that they make cancerous tissues stand out more in images, aiding in detection. Early results suggest they might offer a less invasive method for diagnosing and treating cancer. Although this research remains in the early stages, using nanoparticles could transform how doctors detect and monitor cancer. Participants in this trial will receive one dose of 64Cu-Porphysomes and one dose of unlabelled Porphysomes, which are being tested for their potential to improve imaging and treatment of gynecological cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephanie Lheureux, MD

Principal Investigator

Princess Margaret Cancer Centre/University Health Network

Are You a Good Fit for This Trial?

This trial is for women over 18 with advanced gynecological cancers who have a life expectancy of more than 3 months and are in relatively good physical condition. They must not be pregnant, breastfeeding, or planning curative therapy and should agree to use two effective contraceptives. Participants need adequate organ function and cannot have certain medical conditions or recent investigational drug treatments.

Inclusion Criteria

I am a woman aged 18 or older.

Life expectancy of >3 months

I can perform daily activities with minimal assistance.

Exclusion Criteria

I have had my spleen removed.

Patient has a contraindication to PET/CT imaging, including, but not limited to, phobias associated with imaging (e.g. claustrophobia) and those who cannot lie still in the supine position for at least 20 minutes

Treatment with an investigational drug within 15 days prior to study registration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of 64Cu-PS with one dose of unlabelled PS by intravenous route on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and imaging assessments

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Porphysome Nanoparticles

Trial Overview The study tests PORPHYSOMES (PS) and Copper-64 labelled PORPHYSOMES (64Cu-PS), both nanoparticle suspensions used for PET/CT imaging in patients with metastatic gynecological tumors. It's an open-label, first-in-human trial that gradually increases doses to evaluate safety and effects.

How Is the Trial Designed?

Group I: PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS) Experimental Treatment 2 Interventions

Participants will receive one dose of 64Cu-PS with one dose of unlabelled PS (except for cohort 1) by intravenous (IV) route on Day 1.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/86393f8da0e56b2f/nct06977126-porphysome-nanoparticles-metastatic-gynaecological-cancers

Study to Assess the Safety and Effects of Porphysome ... This is an open-label, first-in-human, dose escalation study evaluating investigational drug PORPHYSOSMES (PS, pegylated porphyrin-lipid ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12515405/

Advances in Nanotechnology in the Diagnosis and ... Nanomaterials show great promise for imaging gynecologic cancers. Nanoparticles as imaging contrast agents can significantly improve the ...

3. withpower.com withpower.com/trial/porphysome-nanoparticles-for-gynecological-cancers-76805

Porphysome Nanoparticles for Gynecological Cancers This trial is for women over 18 with advanced gynecological cancers who have a life expectancy of more than 3 months and are in relatively good physical ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224014392

Advancements in nano-immunotherapy for gynecological ... In this review, we provide an overview of the latest advances in nano-immunotherapy for gynecological cancers, including ovarian, cervical, and endometrial ...

5. oicr.on.ca oicr.on.ca/first-in-class-nanoparticle-to-find-and-treat-cancer-reaching-patients-through-new-clinical-trial/

First-in-class nanoparticle to find and treat cancer reaching ... Health Canada has approved a clinical trial for new technology developed by Toronto-based researchers that offers new, less-invasive ways to manage cancer.

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06977126

Study to Assess the Safety and Effects of Porphysome ... To evaluate the safety and tolerability of PS administration in subjects with advanced metastatic gynaecological cancers. 1 year. Tissue distribution and tumour ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6525988/

Use of Porphysomes to detect primary tumour, lymph node ... Veys et al demonstrated only a moderate sensitivity of 72.6% and a specificity of 54.2% for detection peritoneal metastases in ovarian cancer ...

8. apps.dtic.mil apps.dtic.mil/sti/tr/pdf/AD1024500.pdf

Targeting Ovarian Cancer with Porphysome Nanotechnology As shown in Figure 13, 64Cu-PLP enabled selectively picking up ovarian cancer metastases, where metastases tumors exhibited super bright PET signal while the.