Ivonescimab in the Treatment of Multiple Advanced Tumors

Sponsor
Fudan University
Study ID
NCT06683846
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivocizumab — DRUG
    Administered via intravenous (IV) infusion

Study Details

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

Key Dates

First listed
Nov 12, 2024
Start date
Nov 20, 2024
Status verified
Aug 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab (20mg/kg）in rare tumors
    Participants will receive Ivonescimab 20mg/kg of body weight via intravenous (IV) infusion on Days 1 of a 21-day treatment cycle until disease progression or unacceptable toxicity, or full 2 years of treatment, whichever occurs first.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 12 weeks ]

Central Contacts

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