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Ivonescimab in the Treatment of Multiple Advanced Tumors

ConditionsPheochromocytoma/ParagangliomaRhabdomyosarcomaPaget Disease, ExtramammaryRenal AngiomyolipomaPerivascular Epithelioid Cell Tumor, MalignantSarcomaUrachal CancerNeuroendocrine CancerBasal Cell CarcinomasSarcomatoid CarcinomaPenile CancerAdrenal Cortical CancerGerm Cell Cancer MetastaticNon-Clear Cell Renal Cell CarcinomaProstate CancersClear Cell Renal CancerUrothelial CarcinomaKidney CancerRare Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals able to understand and give written informed consent.

Stage IV disease

Adequate performance status (ECOG 0-2)

Expected survival ≥ 3 months.

Disqualifiers

With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar [FBG] >10mmol/L);

With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10^4 copies/ml; HCV reference: HCV RNA≥2000 IU/ml or ≥10^4 copies/ml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA<10^4 IU/ml, must be treated with antiviral drugs during the trial period to be eligible for enrollment);

History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases;

Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug;

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivocizumab

    Drug

    Administered via intravenous (IV) infusion

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Ivonescimab (20mg/kg）in rare tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

ORR was defined as the proportion of patients who achieved either a complete response (CR) or a partial response (PR) based on the investigator's assessment (RECIST v1.1) that was confirmed by a subsequent scan ≥4 weeks after initial CR/PR.

Time frame
12 weeks

Secondary outcomes

1

Progression-free survival(PFS)

PFS was defined as the time between the enrollment and either RECIST1.1-defined progressive disease or death due to any cause, whichever occurred first.

Time frame
1 year
2

Overall survival (OS)

OS was defined as the time between the enrollment and death due to any cause.

Time frame
2 years
3

Patient-Reported Quality-of-Life(QoL)

Patient-Reported QoL was evaluated according to the European Organization for Research and Treatment of Cancer QOL Core Questionnaire 30 (EORTC QLQ-30) questionaire.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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