Actively Recruiting
Ivonescimab Treatment for Various Advanced Rare Tumors A Phase II Multi-Cohort, Multi-Center 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-1VEGF 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 Pagets 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 20mgkg 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
Research Team
S
Sheng Zhang, Doctor
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here