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Phase II Trial of nab-Sirolimus for Epithelioid Hemangioendothelioma (EHE)

This study is testing a drug called nab-Sirolimus for people with Epithelioid Hemangioendothelioma (EHE), a rare type of cancer, that is either getting worse or causing symptoms. You might be able to join if your EHE can't be cured by surgery and your doctor thinks you need systemic treatment (treatment that affects your whole body). The drug, nab-Sirolimus, is given through a vein (intravenous infusion) on specific days of a 21-day cycle. Researchers will measure how many participants' tumors shrink or stop growing to see if the treatment is successful. The study aims to enroll 41 participants, but its current status is unclear.

Study design
This is a Phase II, single-arm study, meaning everyone receives the same treatment. It is open-label, so both you and your doctors will know you are receiving nab-Sirolimus.
What's involved
You would receive nab-Sirolimus as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle.
Compensation
Not stated in the trial record.
Follow-up
Tumor response will be measured at approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07104331

SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sarcoma Alliance for Research through Collaboration
~41 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:nab-Sirolimus

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor response rate
Measured over Approximately 24 months

Conditions

Epithelioid Hemangioendothelioma (EHE)

Explore related trials

Epithelioid Hemangioendothelioma

NCT07104331

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Sloan Kettering Institute for Cancer Research

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Stanford University

    Stanford, Californiastudy coordinator listed

    Recruiting

  • Washington University St. Louis

    St Louis, Missouristudy coordinator listed

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusettsno site contact published

    Not yet recruiting

  • University of Colorado

    Aurora, Coloradono site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Maria Ahern
[email protected]
650-725-6413
Email the study team

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Eligibility criteria

Inclusion

Participants must have histologically or cytologically confirmed EHE that is either progressing or clinically symptomatic, not a candidate for curative intent surgery, and requires systemic therapy in the opinion of the investigator.
Participants must have measurable disease by RECIST v1.1, 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, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
Age ≥18 years
ECOG performance status ≤2
Participants must meet the following organ and marrow function as defined below:
Platelets \>75,000μl
ANC \>1500μl
Hgb \>9g/dl
Creatinine \<1.5 x ULN or measured CrCl of \>30ml/m2/1.73 m2
Total bilirubin \<2 x ULN
AST/ALT \<3 x ULN
Patients must have recovered from toxicity related to prior therapy to grade \<=1 (defined by CTCAE v5.0) (except alopecia and neuropathy, or immunotherapy related hypothyroidism). Toxicities that are permanent, like hearing loss from platinum agents, may be allowed if agreed to by the medical monitor.
The effects of nab-sirolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of nab-sirolimus administration.
Female patient of childbearing potential has a negative serum pregnancy test within 7 days of study enrollment.
Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged).

Exclusion

Patient with current evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B-C cirrhosis, or uncontrolled medical disease which in the opinion of the investigator or the sponsor could compromise safety and/or assessment of efficacy.
Active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment; those who are PCR positive will be excluded. HIV+ patients are allowed provided the patient has a CD4 count greater than 200 and is HIV undetectable on antiviral medications, and there are no AIDS-defining illnesses within 12 months. The antiviral medication regimen must not contain a strong CYP3A4 inhibitor (eg protease inhibitors).
Major surgical procedure or open surgical biopsy within 28 days of first dose of study drug
Active central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity. Subjects with known CNS metastases that are treated and stable (without evidence of CNS toxicity) and are not requiring systemic steroids are allowed to be enrolled.
Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Myocardial infarction within 12 months of screening
Co-existing malignancies or use of any other concurrent investigational agents or anticancer agents, excluding adjuvant hormonal therapy for breast or prostate cancer.
Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nab-sirolimus, breastfeeding should be discontinued if the mother is treated with nab-sirolimus.

What this trial measures

  • Tumor response rateApproximately 24 months

    To determine ORR by RECIST v1.1 of nab-sirolimus in patients with EHE who require systemic treatment.