Actively Recruiting
Ivonescimab (PD-1/VEGF Bispecific Antibody) for Multiple Advanced Rare Tumors: A Multi-Cohort, Single-Arm Phase II Study
Led by Fudan University · Updated on 2025-08-24
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Ivonescimab, a PD-1/VEGF bispecific antibody, for the treatment of multiple advanced rare tumors. This phase II, multi-cohort, and multi-center study includes 20 different tumor types such as Paget's disease of the scrotum, metastatic paraganglioma, sarcomas, renal carcinomas, prostate cancer, and tumors with brain metastases. The study aims to assess if Ivonescimab improves the objective response rate and prolongs survival, as well as to monitor safety and quality of life during treatment. Participants receive Ivonescimab at a dose of 20mg/kg given by intravenous infusion every 21 days. Treatment continues until disease progression, unacceptable toxicity, or for a maximum of two years. Imaging evaluations are conducted every 9 weeks during the first year and every 12 weeks afterward. Dose delays up to 12 weeks are allowed under specific conditions, but dose reductions are not permitted. Participants undergo a screening period within 28 days before starting treatment. Safety follow-up visits occur 30 days after the last dose, including physical exams and lab tests. Afterward, survival follow-up is done every 3 months for up to one year through visits or phone calls. Researchers track tumor response, progression-free survival, overall survival, quality of life, and record any adverse events throughout the study.
CONDITIONS
Brief Title
Ivonescimab in the Treatment of Multiple Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and give written informed consent
- Histologically or cytologically confirmed diagnosis of one of the specified rare tumors such as Paget's disease of scrotum, paraganglioma, pheochromocytoma, renal angiomyolipoma, sarcomas, prostate or renal cancers
- Stage IV (advanced) disease
- Performance status ECOG 0 to 2
- Expected survival of at least 3 months
- Measurable disease by CT or MRI or skin lesions with infiltration
- Adequate blood counts without ongoing transfusions (hemoglobin > 9 g/dL, ANC > 1,500/mm3, platelets > 100,000/mm3)
- Adequate kidney and liver function within specified limits
- Adequate blood clotting parameters (INR ≤ 1.5, PT ≤ 1.5x ULN, aPTT ≤ 1.5x ULN)
- Willing to use approved contraception during the study and for 120 days after
- Able to comply with study visit schedules and protocol requirements
You will not qualify if you...
- Severe or uncontrolled diseases including high blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg) or poorly controlled diabetes (fasting glucose >10 mmol/L)
- Significant heart conditions such as grade 2 or higher ischemia, arrhythmia (QTc ≥470 ms), or grade 2 or higher heart failure
- Active or uncontrolled serious infections requiring systemic treatment, history of active tuberculosis
- Uncontrolled fluid buildup in chest, abdomen, or heart requiring repeated drainage
- Active hepatitis or viral infections not meeting criteria
- History of immunodeficiency including HIV
- Active autoimmune diseases requiring systemic treatment within past 2 years or judged likely to recur
- Severe allergies or known allergy to study drug or its ingredients
- Recent participation in another clinical trial within 4 weeks
- Live vaccine received within 30 days before first dose or planned during study
- Risk of bleeding, impaired clotting function, or receiving thrombolytic therapy
- History of substance abuse or serious mental illness
- Serious underlying medical, neurological, psychiatric, or unstable conditions that would affect safety or study participation
- Any condition, including psychological or social factors, that would impair ability to complete the study or follow protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days before the first treatment
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years or until disease progression or intolerable toxicity
Participants receive Ivonescimab via intravenous infusion every 3 weeks until disease progression, intolerable toxicity, or for up to 2 years.
Infusions every 3 weeks with imaging reviews every 9 weeks during the first year and every 12 weeks thereafter
Duration - At least 1 year after safety follow-up
Participants undergo safety follow-up 30 days after last treatment, followed by survival follow-up every 3 months for up to 1 year or until death, loss of follow-up, or withdrawal.
1 safety follow-up visit approximately 30 days after last treatment, then survival follow-up visits every 3 months (can be by telephone)
Trial Site Locations
Total: 1 location
1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Sheng Zhang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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