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New treatment option for Pheochromocytoma/Paraganglioma
Official title Ivonescimab in the Treatment of Multiple Advanced Tumors
ClinicalTrials.gov ID: NCT06683846
What this study is testing
What is Ivocizumab?
Ivocizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pheochromocytoma/paraganglioma.
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 Ivonescimab works to treat advanced rare tumors including cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
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
You may be able to join if
- Individuals able to understand and give written informed consent.
- Histologically or cytologically confirmed cancer of one of the following types: PAGET's disease of scrotum with infiltrating sweat gland carcinoma...
- Stage IV disease
- Adequate performance status (ECOG 0-2)
- Expected survival ≥ 3 months.
You likely can't join if
- With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure...
- With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10\^4 copies/ml; HCV reference: HCV...
- History of immunodeficiency, including HIV positive or people with other acquired or congenital immunodeficiency diseases;
- Active autoimmune disease requiring systemic treatment within the past two years, or people with an autoimmune disease that the investigator judges...
- Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;
- Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;
See the full eligibility criteria
- Individuals able to understand and give written informed consent.
- Histologically or cytologically confirmed cancer of one of the following types: PAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant...
- Stage IV disease
- Adequate performance status (ECOG 0-2)
- Expected survival ≥ 3 months.
- Measurable disease by CT or MRI, Or lesions with skin infiltration.
- Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, absolute neutrophil count (ANC) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3).
- Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if...
- Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
- Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction...
- Ability to comply with research visit schedules and other protocol requirements.
- With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar [FBG]...
- With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10\^4 copies/ml; HCV reference: HCV RNA≥2000 IU/ml or ≥10\^4 copies/ml; after nucleoside analog antiviral...
- History of immunodeficiency, including HIV positive or people with other acquired or congenital immunodeficiency diseases;
- Active autoimmune disease requiring systemic treatment within the past two years, or people with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment...
- Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;
- Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;
- History of severe allergies;
- At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy;
- History of substance abuse with an inability to abstain or a history of mental illness;
- people who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the...
- people who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid...
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 study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 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.