RecruitingPhase 2NCT06683846

Ivonescimab in the Treatment of Multiple Advanced Tumors

Ivonescimab (PD-1/VEGF Bispecpecial Antibody) in the Treatment of Multiple Advanced Tumors: a Multi-cohort, Multi-center, Single-arm Phase II Study

Sponsor

Fudan University

Enrollment

400 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma Sarcoma Kidney Cancer Prostate Cancers Penile Cancer Urachal Cancer Paget Disease, Extramammary Neuroendocrine Cancer Pheochromocytoma/Paraganglioma Rhabdomyosarcoma Renal Angiomyolipoma Perivascular Epithelioid Cell Tumor, Malignant Basal Cell Carcinomas Sarcomatoid Carcinoma Adrenal Cortical Cancer Germ Cell Cancer Metastatic Non-Clear Cell Renal Cell Carcinoma Clear Cell Renal Cancer Rare Tumors

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ivonescimab (which targets both the immune system and tumor blood vessel growth) in people with rare, advanced cancers that have limited treatment options. **You may be eligible if...** - You have been diagnosed with one of these rare advanced cancers: Paget's disease of the scrotum, paraganglioma, pheochromocytoma, renal angiomyolipoma, malignant perivascular epithelioid cell tumor (PEComa), rhabdomyosarcoma, or other sarcoma - Your cancer is stage IV (spread to other parts of the body) - You are well enough to carry out daily activities (ECOG 0–2) - Your kidneys, liver, and blood counts are in an acceptable range **You may NOT be eligible if...** - You have uncontrolled high blood pressure, heart disease, or serious infections - You have active hepatitis B or C, or HIV - You have an active autoimmune disease requiring treatment in the past 2 years - You participated in another clinical trial in the last 4 weeks - You have serious psychiatric or neurological conditions such as dementia or epilepsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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