A Study of XmAb23104 in People With Sarcoma

NCT05879185 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 22-195
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Sarcoma

Keywords

XmAb23104; PD-1; ICOS; 22-195

Outcome Measures

Primary Outcomes (1)

• Best Objective Response Rate

  by RECIST v1.1

  24 weeks

Study Arms (1)

XmAb23104 in People With Sarcoma

EXPERIMENTAL

Patients 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.

Biological: XmAb23104

Interventions

XmAb23104 BIOLOGICAL

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.

XmAb23104 in People With Sarcoma

Eligibility Criteria

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Xencor, Inc.: collaborator

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Dr. Ciarra Kelly, MBBCh BAO
• Organization: Memorial Sloan Kettering Cancer Center

kellyc1@mskcc.org

646-888-4312

Study Officials

• Ciara Kelly, MBBCh BAO

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: This phase II, open-label, single-center study.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: April 6, 2023
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (7)