Ivonescimab in the Treatment of Multiple Advanced 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

Conditions

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

Interventions

DRUG

Ivocizumab

Administered via intravenous (IV) infusion

Sponsors & Collaborators

• Fudan University

  lead OTHER

Principal Investigators

• Hongxia Wang, Doctor · Fudan University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-20

Primary Completion

2027-11-30

Completion

2027-11-30

Countries

• China

Study Locations