Trial Outcomes & Findings for A Study of XmAb23104 in People With Sarcoma (NCT NCT05879185)
NCT ID: NCT05879185
Last Updated: 2026-04-13
Results Overview
by RECIST v1.1
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
24 weeks
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
XmAb23104 in People With Sarcoma
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.
XmAb23104: 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.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
XmAb23104 in People With Sarcoma
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.
XmAb23104: 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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease progression, relapse during active treatment
|
4
|
Baseline Characteristics
A Study of XmAb23104 in People With Sarcoma
Baseline characteristics by cohort
| Measure |
XmAb23104 in People With Sarcoma
n=6 Participants
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.
XmAb23104: 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.
|
|---|---|
|
Age, Continuous
|
61.33 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The vendor has decided to close the study early. The study did not enroll sufficient patients to generate meaningful data appropriate to publish.
by RECIST v1.1
Outcome measures
| Measure |
XmAb23104 in People With Sarcoma
n=6 Participants
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.
XmAb23104: 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.
|
|---|---|
|
Best Objective Response Rate
Progression of Disease
|
5 Participants
|
|
Best Objective Response Rate
Not evaluated
|
1 Participants
|
Adverse Events
XmAb23104 in People With Sarcoma
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
XmAb23104 in People With Sarcoma
n=6 participants at risk
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.
XmAb23104: 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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Up to 24 weeks
|
|
General disorders
Death
|
16.7%
1/6 • Up to 24 weeks
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Up to 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Up to 24 weeks
|
Other adverse events
| Measure |
XmAb23104 in People With Sarcoma
n=6 participants at risk
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.
XmAb23104: 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.
|
|---|---|
|
Psychiatric disorders
Panic disorder
|
16.7%
1/6 • Up to 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Up to 24 weeks
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Up to 24 weeks
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • Up to 24 weeks
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity [B/L Knees]
|
16.7%
1/6 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Up to 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Up to 24 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
2/6 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Up to 24 weeks
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
3/6 • Up to 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Up to 24 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
3/6 • Up to 24 weeks
|
|
General disorders
Fatigue
|
33.3%
2/6 • Up to 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Up to 24 weeks
|
|
Investigations
BPH
|
33.3%
2/6 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Up to 24 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
16.7%
1/6 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Up to 24 weeks
|
|
Vascular disorders
Thromboembolic event
|
33.3%
2/6 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
16.7%
1/6 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
2/6 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Up to 24 weeks
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Up to 24 weeks
|
|
Eye disorders
Glaucoma
|
16.7%
1/6 • Up to 24 weeks
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Up to 24 weeks
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Up to 24 weeks
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Up to 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Up to 24 weeks
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular [bilateral arms, face, legs]
|
16.7%
1/6 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Up to 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Up to 24 weeks
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Up to 24 weeks
|
Additional Information
Dr. Ciarra Kelly, MBBCh BAO
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4312
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place