Pilot Study of Ivonescimab in Advanced/Metastatic Cutaneous Angiosarcoma

NCT07655570 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0794NCI-2026-04626
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study evaluating the efficacy and safety of ivonescimab in subjects with advanced or metastatic cutaneous angiosarcoma who have previously been treated with taxane-based chemotherapy.

Conditions

Cutaneous Angiosarcoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with Ivonescimab

EXPERIMENTAL

Participants will be treated with ivonescimab (20 mg/kg IV on Day 1 Q3W). The treatment will be repeated every 3 weeks until progressive disease (PD), intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, lost to follow-up, completion of therapy, death, or any other investigator-determined reasons for treatment discontinuation (whichever occurs first).

Drug: Ivonescimab

Interventions

Ivonescimab DRUG

Given by IV

Also known as: AK-112

Treatment with Ivonescimab

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed cutaneous angiosarcoma that is advanced, metastatic or unresectable.
• Patients must have received prior paclitaxel or docetaxel containing therapy.
• Patients must have measurable disease within 28 days of starting treatment, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, PET or calipers by clinical exam/medical photography.
• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ivonescimab in patients \<18 years of age, children are excluded from this study.
• ECOG performance status ≤1 (Karnofsky ≥60%,).
• Patients must have adequate organ and marrow function as defined below (see Schedule of Activities) :
• Absolute neutrophil count ≥1,500/mcL Platelets ≥100,000/mcL Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). For patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN. For patients with liver metastases, AST and ALT ≤ 5 × ULN.
• Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation Urine protein \< 2+ or 24 hour urine protein quantification \< 1.0 g Coagulation Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy, or prophylactic coagulation). Patients receiving therapeutic anti-coagulation should be on a stable dose.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment .
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen per PI are eligible for this trial.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class NYHA classification 2B or better.
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).
• History of hysterectomy or bilateral salpingo-oophorectomy.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
• Patients who have not recovered from adverse events due to prior anti-cancer therapy (residual toxicities that are \> Grade 2 by CTCAE v 5.0) with the exception of alopecia.
• Patients who are receiving any other investigational agents.
• Patients who have received prior immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 drugs).
• Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrollment, potential need for CNS radiation within the first cycle, or leptomeningeal disease.
• Note: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).
• Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to enrollment, however the following will be allowed:
• Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.
• Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted
• Current use of systemic corticosteroids (\>10 mg daily prednisone or equivalent)
• Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab (immune checkpoint inhibition antibodies, antiangiogenic antibodies).
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.0
• Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

Study Officials

• Michael Nakazawa, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Nakazawa, MD

CONTACT

713-785-7017; msnakazawa@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

US (1)