Ivonescimab in the Treatment of Multiple Advanced Tumors

NCT06683846 | Recruiting Phase 2 DMC

• 1 other identifier: AK112-US-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rare tumor; Ivocizumab; immunotherapy

Outcome Measures

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.

  12 weeks

Secondary Outcomes (3)

• Progression-free survival(PFS)

  1 year

• Overall survival (OS)

  2 years

• Patient-Reported Quality-of-Life(QoL)

  1 year

Study Arms (1)

Ivonescimab (20mg/kg）in rare tumors

EXPERIMENTAL

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.

Drug: Ivocizumab

Interventions

Ivocizumab DRUG

Administered via intravenous (IV) infusion

Ivonescimab (20mg/kg）in rare tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals able to understand and give written informed consent.
• Histologically or cytologically confirmed cancer of one of the following types:
• PAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom
• Stage IV disease
• Adequate performance status (ECOG 0-2)
• Expected survival ≥ 3 months.
• Measurable disease by CT or MRI, Or lesions with skin infiltration.
• Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, absolute neutrophil count (ANC) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3).
• Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
• Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
• Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.
• Ability to comply with research visit schedules and other protocol requirements.

You may not qualify if:

• 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);
• ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage;
• 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;
• Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;
• Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;
• History of severe allergies;
• At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy;
• History of substance abuse with an inability to abstain or a history of mental illness;
• Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the investigator, have other reasons not to be enrolled; Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility;
• Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid disorders, and mental illness), or who have a serious and/or unstable medical, psychological, or other condition (including laboratory abnormalities) that would affect the subject's safety or the subject's ability to provide informed consent, or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma; Rhabdomyosarcoma; Paget Disease, Extramammary; Angiomyolipoma; Perivascular Epithelioid Cell Neoplasms; Sarcoma; Urachal cancer; Carcinoma, Neuroendocrine; Carcinoma, Basal Cell; Carcinoma; Penile Neoplasms; Prostatic Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Adipose Tissue; Neoplasms, Basal Cell; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Prostatic Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Study Officials

• Hongxia Wang, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Zhang, Doctor

CONTACT

021-64175590; wozhangsheng@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of oncology department

Model Details: single-arm, multi-cohort

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)