Actively Recruiting
Ivonescimab in the Treatment of Multiple Advanced Tumors
Led by Fudan University · Updated on 2025-08-24
400
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. cohort 3: Metastatic renal angiomyolipoma and malignant perivascular epithelioid cell tumor. cohort 4: Rhabdomyosarcoma and Ewing's sarcoma cohort 5: Collecting duct carcinoma cohort 6: Urachal carcinoma. cohort 7: Neuroendocrine cancer. cohort 8: Basal cell carcinoma and sarcomatoid carcinoma. cohort 9: Penile cancer. cohort 10: Adrenal cortical cancer. cohort 11: Metastatic germ cell tumors, failure of standard cisplatin based therapy (mostly testicular cancer). cohort 12: Non-clear cell renal carcinoma (including renal papillary renal carcinoma); Renal cancer cannot be classified). cohort 13: Non-clear cell renal carcinoma (including chromophobe renal carcinoma) cohort 14: Other rare tumors that cannot be classified (such as testicular reticulum adenocarcinoma, etc.). cohort 15: Prostate cancer. cohort 16: Clear cell renal carcinoma. (16.1: received PD-1; 16.2: no PD-1 received) cohort 17: Urothelial carcinoma. cohort 18: Kidney cancer with brain metastases. cohort 19: Brain metastases of urothelial carcinoma. cohort 20: Rare tumors with brain metastases. It will also learn about the safety of Ivonescimab. The main questions it aims to answer are: Does Ivonescimab improve the objective response rate and prolong the survival of participants? What medical problems do participants have when taking Ivonescimab? Participants will: Receive Ivonescimab 20mg/kg intravenously every 21 days until disease progression, intolerable toxicity, or full 2 years of treatment, whichever occurs first. Be performed imaging evaluation according to RECIST 1.1 every 9 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria
CONDITIONS
Official Title
Ivonescimab in the Treatment of Multiple Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Diagnosed with one of the specified advanced cancers confirmed by histology or cytology
- Stage IV disease
- ECOG performance status between 0 and 2
- Expected survival of at least 3 months
- Measurable disease by CT or MRI or skin infiltration lesions
- Adequate blood counts without ongoing transfusions (hemoglobin >9 g/dL, ANC >1500/mm3, platelets >100,000/mm3)
- Adequate kidney and liver function (creatinine ≤2.0 x institutional upper limit; bilirubin ≤1.5 x upper limit; AST and ALT ≤3 x upper limit or ≤5 x if liver metastases present)
- Adequate coagulation function (INR ≤1.5, PT ≤1.5 x upper limit, aPTT ≤1.5 x upper limit)
- Willing to use medically approved contraception during the study and for 120 days after
- Able to comply with visit schedules and protocol requirements
You will not qualify if you...
- Severe or uncontrolled diseases including poor blood pressure control (systolic ≥150 mmHg or diastolic ≥100 mmHg), uncontrolled diabetes (fasting blood sugar >10 mmol/L), severe heart conditions (myocardial ischemia, infarction, arrhythmia, heart failure)
- Active or uncontrolled severe infections requiring systemic treatment, or history of active tuberculosis
- Uncontrolled fluid build-up such as ascites, pleural or pericardial effusion requiring repeated drainage
- Active hepatitis with elevated liver enzymes or high viral loads unless controlled with treatment
- History of immunodeficiency including HIV or other acquired/congenital immune diseases
- Active autoimmune disease needing systemic treatment within the past 2 years or judged likely to recur
- Severe allergic reactions to monoclonal antibodies or known allergy to study drug components
- Participation in another clinical trial within 4 weeks before enrollment
- Receipt or planned receipt of live vaccines within 30 days before first dose
- History of severe allergies or bleeding risk, or receiving blood thinners
- Substance abuse or mental illness impairing study participation
- Serious underlying conditions or neurological/psychiatric disorders affecting safety or compliance
- Any condition that might affect the study protocol, follow-up, or informed consent capability including psychological, social, or geographic factors
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Sheng Zhang, Doctor
CONTACT
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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