Your session is about to expire
← Back to Search
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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,804 Total Patients Enrolled
70 Trials studying Sarcoma
13,761 Patients Enrolled for Sarcoma
Xencor, Inc.Industry Sponsor
29 Previous Clinical Trials
2,747 Total Patients Enrolled
1 Trials studying Sarcoma
300 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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations are participating in the trial?
"There are 7 clinical trial sites for this particular study, including the Memorial Sloan Kettering Monmouth in Middletown, the Memorial Sloan Kettering Bergen in Montvale and the Memorial Sloan Kettering Suffolk - Commack in Commack. Additionally, there are 4 other locations hosting trials at present."
Answered by AI
How many individuals are being administered this treatment in the course of the research?
"Affirmative. Information located on clinicaltrials.gov confirms that this scientific trial, initially posted on April 6th 2023, is actively enlisting volunteers. 30 participants need to be enlisted from 7 distinct sites."
Answered by AI
Has the FDA approved XmAb23104 for people with sarcoma?
"XmAb23104's safety is evaluated as a 2 on Power's scale due to the lack of efficacy data from its Phase 2 trial, but there is some evidence demonstrating that it can be safe for use in people with sarcoma."
Answered by AI
Are any additional participants being accepted into this clinical investigation?
"Affirmative. An examination of clinicaltrials.gov demonstrates that this experiment, which was first made available on April 6th 2023, is currently in pursuit of participants. Specifically, they need 30 individuals to join from 7 distinct sites."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger