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Monoclonal Antibodies
XmAb23104 for Sarcoma
Phase 2
Waitlist Available
Led By Ciara Kelly, MBBCh BAO
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Summary
This trial is testing if a new drug, XmAb23104, is effective & safe for advanced sarcoma. Researchers will measure side effects.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While the exact side effects aren't listed here, typical ones from similar treatments may include immune system reactions, fatigue, allergic responses to the drug components, digestive issues like nausea or diarrhea, skin reactions at injection sites, and possible blood-related problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
best objective response rate
Trial Design
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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,550 Total Patients Enrolled
70 Trials studying Sarcoma
13,705 Patients Enrolled for Sarcoma
Xencor, Inc.Industry Sponsor
29 Previous Clinical Trials
2,442 Total Patients Enrolled
1 Trials studying Sarcoma
198 Patients Enrolled for Sarcoma
Ciara Kelly, MBBCh BAOPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Sarcoma
41 Patients Enrolled for Sarcoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well enough for treatment.I haven't had serious heart problems in the last 6 months.I do not have any other cancer that needs treatment.I have not taken antibiotics in the last 14 days.I have not received a live-virus vaccine in the last 30 days.I am not on immunosuppressive medication, except for allowed types and doses.I am not pregnant or breastfeeding.I have had an organ or stem-cell transplant.I am currently on medication for an infection.I am 18 years old or older.My kidneys work well enough to clear waste from my blood.I have hepatitis but it's under control or resolved.I have an active tuberculosis infection.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use effective birth control during and for 8 weeks after the study.I am willing to follow the trial's rules and agree to necessary biopsies.I am able and willing to sign the consent form.I haven't had PD-1 or PD-L1 antibody treatment in the last 8 weeks.My condition worsened or I couldn't tolerate my previous cancer treatment.I haven't had cancer treatment in the last 3 weeks.My target cancer lesion has grown after previous radiation.I have a specific type of advanced sarcoma and may have had prior treatment with immune therapy.I am HIV positive, on treatment for at least 4 weeks, with low viral load and no recent severe infections.I have stable brain metastases and haven't used steroids in the last 14 days.I have not had significant immune system issues or treatments that weaken my immune system recently.
Research Study Groups:
This trial has the following groups:- Group 1: XmAb23104 in People With Sarcoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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