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SarcomaPhase 2NCT05879185

A Study of XmAb23104 in People With Sarcoma

A Phase 2 study testing XmAb23104 in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to find out whether the study drug, XmAb23104, is an effective treatment for advanced sarcoma. The researchers will also look at whether XmAb23104 is safe and causes few or mild side effects in participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
XmAb23104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
7 sitesUnited States
Study dates
6 Apr 2023to 19 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age ≥ 18 years at the time of informed consent
  • Be capable, willing, and able to provide written informed consent/assent
  • Be willing to comply with clinical trial instructions and requirements, including mandatory biopsies at baseline and on-treatment where feasible
  • Patients must have progressed on or be intolerant of at least one prior standard systemic therapy where available. If a patient declines standard systemic therapy they will be considered eligible.
  • Patients must have a histologically confirmed locally advanced/metastatic sarcoma with select histological subtypes including
  • i) malignant solitary fibrous tumor (SFT)
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  • ii) leiomyosarcoma (LMS)
  • iii) dedifferentiated chondrosarcoma
  • iv) undifferentiated pleomorphic sarcoa/myxofibrosarcoma (Patients with UPS/MFS will be eligible if they have refractory to or relapsed after anti-PD-(L)1 therapy and demonstrated clinical benefit to immunecheckpoint inhibition [complete/partial response or stable disease >/=6 months])
  • v) sclerosing epithelioid fibrosarcoma (SEF) or extraskeletal myxoid chondrosarcoma (ESMC)
  • vi) pecoma.
  • Adequate performance status: ECOG 0 or 1/KPS 100-70%
  • Expected life expectancy >3 months
  • Presence of measurable disease per RECIST v1.1.
  • o Target lesion(s) must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment
  • Adequate organ function determined within 10 days of treatment initiation
  • Platelet count > 100 x 10^9/L
  • Hemoglobin level > 8.0 g/dL
  • Absolute neutrophil count > 1.0 x 10^9/L
  • AST at screening < 3 x ULN for subjects without known liver involvement by tumor; or < 5 x ULN for subjects with known liver involvement by tumor
  • ALT at screening < 3 x ULN for subjects without known liver involvement by tumor; or < 5 x ULN for subjects with known liver involvement by tumor
  • Bilirubin ≤ 1.5 × ULN (unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)
  • Estimated creatinine clearance (CL) > 30 mL/min calculated by the Cockcroft-Gault or modification of diet in renal disease formulas
  • Female subjects of childbearing potential must agree to use a highly effective method of birth control during and for 8 weeks after completion of study. Women are considered to be of childbearing potential unless it is documented that they are over the age of 60 OR postmenopausal by history with no menses for 1 year and confirmed by FSH OR have a history of hysterectomy and/or bilateral oophorectomy OR have a history of bilateral tubal ligation. Highly effective methods of birth control include hormonal birth control (oral, intravaginal, transdermal, implantable, or intrauterine device [IUD]), IUDs (non-hormonal), vasectomy (in male partner), or any double-barrier methods (combination of male condom and spermicide with either cap, diaphragm, or sponge).

Who cannot join

  • History of unstable or deteriorating cardiovascular disease within the previous 6 months prior to screening including but not limited to the following:
  • Unstable angina or myocardial infarction
  • CVA/stroke
  • Congestive heart failure (New York Heart Association [NYHA] Class III or IV
  • Uncontrolled clinically significant arrhythmias
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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  • Patients with previously treated brain metastases or carcinomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases on imaging performed during study screening, and are not using steroids for at least 14 days prior to trial treatment
  • Current use of immunosuppressive medication, EXCEPT for the following:
  • intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
  • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Evidence of clinically significant immunosuppression such as the following:
  • Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
  • Concurrent opportunistic infection
  • Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment
  • History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease
  • A life threatening (Grade 4) immune related adverse event related to prior immunotherapy.
  • Failure to recover from any immune related adverse event from prior anti-cancer therapy to grade ≤ 1, with the exception of alopecia or endocrinopathies that are managed and stable on hormone replacement therapy.
  • Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2 except for alopecia and peripheral neuropathy related to prior chemotherapy
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) disease that is not controlled HIV positive patients will be considered eligible if:
  • Established ART for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment
  • CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
  • No opportunistic infection within the past 12 months
  • Patients known to be positive for active Hepatitis B (HBsAg reactive with detectable HBV DNA), or Hepatitis C (HCV RNA (qualitative) is detected)
  • Patients with chronic hepatitis B (positive HBsAg and/or HBcAb and negative HBV DNA by PCR) are eligible for this study if they are on suppressive anti-viral therapy and deemed safe by a gastroenterologist
  • Patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution will be considered eligible.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Women who are pregnant or breastfeeding
  • Patients expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment(s)
  • Prior organ transplantation including allogenic stem-cell transplantation
  • Active infection requiring systemic therapy
  • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5 Grade ≥ 3)
  • Prior treatment with an investigational anti-ICOS therapy
  • Treatment with a PD-1 or PD-L1 antibody within 8 weeks of the start of study therapy.
  • Treatment with any other anticancer therapy within 3 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.).
  • Treatment with antibiotics within 14 days prior to first dose of study drug
  • Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (vaccines that do not contain live virus are permitted).
  • Presence of any other active malignancy requiring systemic therapy that may influence the outcome of this study.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Rockville Centre, New York, 11553

Other trials in United States

About this study

Official title: Phase II Study of XmAb23104 (Targeting PD-1 and ICOS), in Patients With Advanced Sarcoma

The purpose of this study is to find out whether the study drug, XmAb23104, is an effective treatment for advanced sarcoma. The researchers will also look at whether XmAb23104 is safe and causes few or mild side effects in participants.

Conditions
Sarcoma
Being tested
XmAb23104
Keywords
XmAb23104, PD-1, ICOS, 22-195
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XmAb23104Biological

    XmAb23104 (10 mg/kg) intravenously on days 1 and 15 of each 28-day cycle. XmAb23104 will be administered by IV infusion at a constant rate over 1 hour.

Study groups in NCT05879185
Study groupRoleWhat they receive
XmAb23104 in People With SarcomaExperimentalPatients will receive the recommended phase II dose of XmAb23104 monotherapy on day 1 and 15 of each 28-day cycle. Patients will continue XmAb23104 (day 1 \& 15, q 28 days) for up to 24 months depending on their response and tolerability to treatment. Treatment will be continued until progressive disease (PD) or toxicity or a total of 24 months of study therapy has been completed.
Receives: Biological: XmAb23104

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Objective Response Rate

    by RECIST v1.1

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start6 Apr 2023
  3. Primary completion19 Jul 2024
  4. Study completion19 Jul 2024

Why it stopped: Vendor decided study to be closed early

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This phase II, open-label, single-center study.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05879185
Sponsor's protocol ID
22-195
Status last verified
Sep 2024
First submitted
18 May 2023
Last updated
13 Apr 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XmAb23104 in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Objective Response Rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05879185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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