XmAb23104 for Sarcoma

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byCiara Kelly, MBBCh BAO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ciara Kelly, MBBCh BAO

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults (≥18 years) with advanced sarcoma who have tried at least one standard treatment and are not responding well or can't tolerate it. They must be able to consent, follow trial procedures, and have a life expectancy over 3 months. Participants need measurable disease per specific criteria, good performance status, and proper organ function. Women of childbearing potential must use effective birth control during the study.

Inclusion Criteria

My organs are working well enough for treatment.

Presence of measurable disease per RECIST v1.1.

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

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Exclusion Criteria

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)

I haven't had serious heart problems in the last 6 months.

I do not have any other cancer that needs treatment.

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Treatment Details

Interventions

XmAb23104 (Monoclonal Antibodies)

Trial OverviewThe trial is testing XmAb23104's effectiveness for treating advanced sarcoma. It will also assess the safety profile of XmAb23104 and monitor how mild or severe any side effects are in participants.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: XmAb23104 in People With SarcomaExperimental Treatment1 Intervention

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.