BridgeMD
Tests treatment safety and results for Gynecological Cancers
Official title Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
ClinicalTrials.gov ID: NCT06977126
What this study is testing
What is PORPHYSOMES?
PORPHYSOMES is an investigational medicine, being studied as a potential treatment for gynecological cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Patient is able to understand and is willing to sign a written informed consent document prior to registration/enrollment on to study.
You likely can't join if
- 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...
- Patients receiving nuclear medicine scans with other radiopharmaceutical agents (ex: 18F-FDG or other) during the study's exclusionary period will be...
- 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...
See the full eligibility criteria
- 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.
- 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...
- Baseline corrected QT (QTc) interval prolongation \< 470 milliseconds.
- Within 8 days of the proposed enrollment patients must have adequate organ function.
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.