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New treatment option for Extramammary Paget Disease
Official title A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease
ClinicalTrials.gov ID: NCT07117851
What this study is testing
What is Disitamab Vedotin combined with Bicalutamide?
Disitamab Vedotin combined with Bicalutamide is an investigational medicine, being studied as a potential treatment for extramammary paget disease.
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
- The goal of this clinical trial is to learn if Disitamab Vedotin combined with Bicalutamide works to treat advanced HER2-positive and AR- positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination.
- Phase 2: a mid-size study of how well it works
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, men only
You may be able to join if
- Voluntarily sign the informed consent form and comply with the requirements of the protocol.
- Age ≥ 18 years old.
- Confirmed diagnosis by histological examination and/or cytological examination, combined with imaging or ultrasound assessment for mammary and...
- ECOG score: 0 to 1.
- At least one measurable lesion (according to the RECIST criteria, non-nodal lesions with a longest diameter on CT scan ≥10 mm, and nodal lesions with...
You likely can't join if
- Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ...
- Have had active autoimmune diseases within 2 years prior to the start of the study treatment that required systemic treatment (such as the use of...
- The dose is \>10mg/day of prednisone or other equivalent hormones, and it is within 2 weeks of the first administration and still in use;
- Have a history of active tuberculosis;
- Have uncontrollable, recurrent drainage of ascites, pericardial effusion, or pleural effusion;
- Have undergone major organ transplantation;
See the full eligibility criteria
- Voluntarily sign the informed consent form and comply with the requirements of the protocol.
- Age ≥ 18 years old.
- Confirmed diagnosis by histological examination and/or cytological examination, combined with imaging or ultrasound assessment for mammary and extramammary Paget's disease; pathologically confirmed as HER2 positive...
- ECOG score: 0 to 1.
- At least one measurable lesion (according to the RECIST criteria, non-nodal lesions with a longest diameter on CT scan ≥10 mm, and nodal lesions with a shortest diameter on CT scan ≥15 mm); or skin lesions that can be...
- Adequate organ function: Blood routine: Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L, Platelet (PLT) ≥70×10\^9/L, Hemoglobin (HGB) ≥80g/L; Liver function: Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN)...
- Estimated life expectancy ≥3 months.
- Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Have had active autoimmune diseases within 2 years prior to the start of the study treatment that required systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants), except...
- The dose is \>10mg/day of prednisone or other equivalent hormones, and it is within 2 weeks of the first administration and still in use;
- Have a history of active tuberculosis;
- Have uncontrollable, recurrent drainage of ascites, pericardial effusion, or pleural effusion;
- Have undergone major organ transplantation;
- Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the study treatment; or have chronic non-healing wounds or fractures;
- Have a history of live attenuated vaccine administration within 14 days prior to the start of the study treatment or plan to receive live attenuated vaccine vaccination during the study period;
- Have had a severe hypersensitivity reaction after the use of monoclonal antibodies; known allergy to the active ingredients or excipients of this study drug;
- Within 4 weeks prior to the start of the study, are participating in or have participated in other clinical studies;
- Have a history of severe allergies;
- Have a risk of bleeding, or coagulation dysfunction, or are currently receiving -thrombolytic therapy;
- Have a history of substance abuse and are unable to quit or have mental disorders;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study, or there are other reasons deemed unsuitable for...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. 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.