Trial Outcomes & Findings for A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies (NCT NCT04927884)
NCT ID: NCT04927884
Last Updated: 2024-06-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
30 days after last dose, up to 65 weeks and 5 days
Results posted on
2024-06-12
Participant Flow
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
Participant milestones
| Measure |
Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects
Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) Sacituzumab govitecan-hziy 7.5 mg/kg IV for all subjects N-803: Dose: 15 μg/kg subcutaneously (SC)
Frequency: administered on Day 8 of each cycle (every 3 weeks)
PD-L1 t-haNK: Dose: \~2 × 10\^9 cells intravenously (IV)
Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects
Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) Sacituzumab govitecan-hziy 7.5 mg/kg IV for all subjects N-803: Dose: 15 μg/kg subcutaneously (SC)
Frequency: administered on Day 8 of each cycle (every 3 weeks)
PD-L1 t-haNK: Dose: \~2 × 10\^9 cells intravenously (IV)
Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)
|
|---|---|
|
Overall Study
Progressive Disease
|
2
|
Baseline Characteristics
A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies
Baseline characteristics by cohort
| Measure |
Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects
n=3 Participants
Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) Sacituzumab govitecan-hziy 7.5 mg/kg IV for all subjects N-803: Dose: 15 μg/kg subcutaneously (SC)
Frequency: administered on Day 8 of each cycle (every 3 weeks)
PD-L1 t-haNK: Dose: \~2 × 10\^9 cells intravenously (IV)
Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)
|
|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 15.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Histologically confirmed stage IV TNBC. Subjects must have had at least 2 prior treatments for TNBC
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose, up to 65 weeks and 5 daysOutcome measures
| Measure |
All Subjects
n=3 Participants
Number of participants
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
3 Participants
|
Adverse Events
Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects
n=3 participants at risk
Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) Sacituzumab govitecan-hziy 7.5 mg/kg IV for all subjects N-803: Dose: 15 μg/kg subcutaneously (SC)
Frequency: administered on Day 8 of each cycle (every 3 weeks)
PD-L1 t-haNK: Dose: \~2 × 10\^9 cells intravenously (IV)
Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)
|
|---|---|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Nervous system disorders
Central nervous system lesion
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
Other adverse events
| Measure |
Sacituzumab Govitecan-hziy 7.5 mg/kg IV for All Subjects
n=3 participants at risk
Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) Sacituzumab govitecan-hziy 7.5 mg/kg IV for all subjects N-803: Dose: 15 μg/kg subcutaneously (SC)
Frequency: administered on Day 8 of each cycle (every 3 weeks)
PD-L1 t-haNK: Dose: \~2 × 10\^9 cells intravenously (IV)
Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Chills
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Fatigue
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Injection site pain
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Injection site pruritus
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Pain
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Chest pain
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Feeling jittery
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Injection site erythema
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Infections and infestations
COVID-19
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Infections and infestations
Wound infection
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
3/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Metabolism and nutrition disorders
Dyspnoea
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Nervous system disorders
Central nervous system lesion
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Nervous system disorders
Cognitive linguistic deficit
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Psychiatric disorders
Restlessness
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Eye disorders
Swelling of eyelid
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Immune system disorders
Contrast media allergy
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
|
Vascular disorders
Lymphoedema
|
33.3%
1/3 • 30 days after last dose, up to 65 weeks and 5 days weeks or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
Only the Phase 1b portion of the study enrolled participants at the 7.5 mg/kg Sacituzumab Govitecan-Hziy dose level. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place