Trials / Recruiting

RecruitingNCT06683846

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 400 (estimated)

Sponsor: Fudan University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, multi-cohort phase II study. Primary objectives is to evaluate the objective response rate (ORR) of Ivonescimab in the treatment of multiple rare advanced tumors. Secondary objectives is to evaluate the imaging progression-free survival (PFS), overall survival (OS), quality of life (QoL), and safety in the treatment of multiple rare advanced tumors with Ivonescimab. A total of 20 cohorts were included: 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. Sample size: using one stage binomial design with power 80% and unilateral alpha value 0.1, it is expected that less than 5% will be ineffective, while 20% will be effective. Considering 10% loss of follow-up, 19 cases will be required. Calculate 20 people per cohort. A total of 400 patients were enrolled. The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up). Screening period: Participants are required to undergo a screening period within 28 days prior to the study's first treatment to determine eligibility. Duration of treatment: Patients were treated with ebraxizumab (20mg/kg Q3W every 3 weeks) until disease progression or intolerability of toxicity, or ebraxizumab for 2 years. Reviews were performed every 9 weeks for 1 year of treatment and every 12 weeks after 1 year. Follow-up period: The safety follow-up period began after the last study treatment, and was followed up once on the 30th day (±7 days). Subjects should go to the research center for the examination of vital signs, physical examination, laboratory examination and other protocol requirements, and evaluate AE, concomitant medication and concomitant treatment. After the end of the safety follow-up period, the subjects entered the 1-year survival follow-up period, which was conducted every 3 months. They could be visited by telephone follow-up and other effective ways to collect survival information and follow-up treatment information. Survival follow-up lasted until death, loss of follow-up, withdrawal of informed consent, or investigator termination of the study. Administration regimen: Ivonescimab (AK112), 20mg/kg, 21 days in a cycle, with not less than 90 minutes (±10 minutes) of intravenous infusion, the infusion time can be extended to a maximum of 240 minutes, continuous administration until disease progression, intolerable toxicity, or 2 years of treatment. Dose adjustment of AK112 is not permitted during treatment, but delayed dosing is permitted for up to 12 weeks (since the last dosing time) if AK112 is discontinued for more than 12 weeks due to glucocorticoid administration for irAE, or if there is an AE that may be unrelated or unrelated to AK112 due to treatment. In both cases that led to the suspension of AK112 for more than 12 weeks, the investigators determined that the patient would benefit from continued treatment and could be allowed to delay treatment for more than 12 weeks.

Conditions

Interventions

Type	Name	Description
DRUG	Ivocizumab	Administered via intravenous (IV) infusion

Timeline

Start date: 2024-11-20
Primary completion: 2027-11-30
Completion: 2027-11-30
First posted: 2024-11-12
Last updated: 2025-08-24

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06683846. Inclusion in this directory is not an endorsement.