Testing PORPHYSOMES with 64Cu-PORPHYSOMES for gynecological cancers
Official title: Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
First-in Human Clinical Trial Assessing Porphysome Nanoparticles for Biodistribution and Safety, in Imaging of Advanced Metastatic Gynaecological Cancers
- Phase 1
- 1 group
- One site, in Toronto
- Recruiting
Interventions
- Medication
PORPHYSOMES
Pegylated porphyrin-lipid conjugate-containing nanoparticle suspension
- Medication
64Cu-PORPHYSOMES
Pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Female patients age ≥ 18 years.
- +Life expectancy of \>3 months.
- +Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- +Patient is able to understand and is willing to sign a written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → document prior to registration/enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → on to study.
- +Patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → corrected QT (QTc) interval prolongation \< 470 milliseconds.
- +Within 8 days of the proposed enrollment patients must have adequate organ function.
- +Patients of childbearing potential (as assessed by their local InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →) and their partners who are sexually active must agree to the use of 2 highly effective forms of contraception throughout the period of study treatment and for 12 months after last dose of study drug.
- +Histologically confirmed metastatic advanced gynecological cancer. All epithelial subtypes are permitted. Patients receiving standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → oncological treatment (i.e. chemotherapy and/or radiation) will be included.
Exclusion
- −History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- −Patient is a candidate for therapy with curative intent.
- −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.
- −Patients receiving nuclear medicine scans with other radiopharmaceutical agents (ex: 18F-FDG or other) during the study's exclusionary period will be excluded from the study.
- −Patients with known myelodysplastic syndrome/acute myeloid leukemia.
- −Treatment with an investigational drug within 15 days prior to study registration.
- −Patients with a known active COVID-19 infection at the time of registration/enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- −Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → would make the subject inappropriate for entry into this study.
- −Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- −Unresolved toxicity \> CTCAE grade 1 from previous anti-cancer therapies, including radiotherapy, with exception.
- −Retinopathy ≥ grade 2.
- −Patients with porphyria.
- −Patients that have undergone a splenectomy.
- −Pregnant or breast-feeding women.
- −Patients must not receive any other oncological treatments, including chemotherapy and/or radiation, within 2 weeks before starting study drug administration (and for 28 days after study drug administration).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to identify or measure a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study receives PORPHYSOMES and 64Cu-PORPHYSOMES.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 24 people.
The study is currently expected to finish around November 2027.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of Dose Limiting Toxicities (DLTs) — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06977126 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PORPHYSOMESDrug
Pegylated porphyrin-lipid conjugate-containing nanoparticle suspension
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 64Cu-PORPHYSOMESDrug
Pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2027-11-19.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 24 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is an open-label, first-in-human, dose escalation study evaluating investigational drug PORPHYSOSMES (PS, pegylated porphyrin-lipid conjugate-containing nanoparticle suspension) and 64Cu-PORPHYSOMES (64Cu-PS, pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension) for PET/CT imaging assessments in patients with metastatic/advanced gynecological tumors.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.