Gynecological CancersPhase 1NCT06977126
Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
A Phase 1 study testing PORPHYSOMES and 64Cu-PORPHYSOMES in people with Gynecological Cancers, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Cancers
- What is being tested?
- PORPHYSOMES and 64Cu-PORPHYSOMES
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2025to 19 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Female patients age ≥ 18 years.
- Life expectancy of >3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Histologically confirmed metastatic advanced gynecological cancer. All epithelial subtypes are permitted. Patients receiving standard of care oncological treatment (i.e. chemotherapy and/or radiation) will be included.
- Patient is able to understand and is willing to sign a written informed consent document prior to registration/enrollment on to study.
- Patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Show all 9Show fewer
- Patients of childbearing potential (as assessed by their local Investigator) 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.
- Baseline corrected QT (QTc) interval prolongation < 470 milliseconds.
- Within 8 days of the proposed enrollment patients must have adequate organ function.
Who cannot join
- 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 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).
Show all 15Show fewer
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- Patients with a known active COVID-19 infection at the time of registration/enrollment.
- 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 Investigator 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.
- Pregnant or breast-feeding women.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Stephanie Lheureux, MD
About this study
Official title: First-in Human Clinical Trial Assessing Porphysome Nanoparticles for Biodistribution and Safety, in Imaging of Advanced Metastatic Gynaecological Cancers
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.
- Conditions
- Gynecological Cancers
- Being tested
- PORPHYSOMES, 64Cu-PORPHYSOMES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PORPHYSOMESDrug
Pegylated porphyrin-lipid conjugate-containing nanoparticle suspension
64Cu-PORPHYSOMESDrug
Pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension
| Study group | Role | What they receive |
|---|---|---|
| PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS) | Experimental | 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. Receives: Drug: PORPHYSOMES; Drug: 64Cu-PORPHYSOMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)
To determine the recommended dose of PORPHYSOME.
Measured: 1 year
Secondary outcomes (4)
Incidence of AEs
To evaluate the safety and tolerability of PS administration in subjects with advanced metastatic gynaecological cancers.
Measured: 1 year
Tissue distribution and tumour uptake kinetics
To identify the tissue distribution and tumour uptake of escalating PS drug doses.
Measured: 1 year
Concentration-time curves
To identify the plasma pharmacokinetic profiles of escalating PS drug doses.
Measured: 1 year
Image- and model-based organ dosimetry
To estimate the radiation dosimetry of 64Cu-PS in healthy organ structures.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start18 Nov 2025
- Primary completion18 Nov 2026 (estimated)
- Study completion19 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological CancersStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Lheureux, MD, Principal investigator, Princess Margaret Cancer Centre/University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977126
- Sponsor's protocol ID
- OZUHN-005
- Status last verified
- Jan 2026
- First submitted
- 8 May 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in Human Clinical Trial Assessing Porphysome Nanoparticles for Biodistribution and Safety, in Imaging of Advanced Metastatic Gynaecological Cancers
- ClinicalTrials.gov ID
- NCT06977126
- Acronym / sponsor ID
- OZUHN-005
- Conditions
- Gynecological Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 19 Nov 2027 (estimated)
- First posted
- 18 May 2025 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS) | Experimental | Drug: PORPHYSOMES, Drug: 64Cu-PORPHYSOMESParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients age ≥ 18 years.
- Life expectancy of >3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Histologically confirmed metastatic advanced gynecological cancer. All epithelial subtypes are permitted. Patients receiving standard of care oncological treatment (i.e. chemotherapy and/or radiation) will be included.
- Patient is able to understand and is willing to sign a written informed consent document prior to registration/enrollment on to study.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| PORPHYSOMESPegylated porphyrin-lipid conjugate-containing nanoparticle suspension | Drug | PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS) |
| 64Cu-PORPHYSOMESPegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension | Drug | PORPHYSOMES and 64Cu-PORPHYSOMES (64Cu-PS) |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 1 year
To determine the recommended dose of PORPHYSOME.
4 secondary outcomes
Incidence of AEs
Time frame: 1 year
Tissue distribution and tumour uptake kinetics
Time frame: 1 year
Concentration-time curves
Time frame: 1 year
Image- and model-based organ dosimetry
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Gynecological Cancers
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 1/2
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
Tumours, Gynecological
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
RecruitingObservational study
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Gynaecological Cancers
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.
Stephanie Lheureux, MD principal investigator
Princess Margaret Cancer Centre/University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PORPHYSOMES and 64Cu-PORPHYSOMES in people with Gynecological Cancers, run by University Health Network, Toronto at 1 site in Canada.
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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Lheureux, MD (416-946-2818, stephanie.lheureux@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLTs) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.