- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631552
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer
The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I.
Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).
Study Overview
Status
Conditions
- Cervical Cancer
- Urinary Bladder Neoplasms
- Small Cell Lung Cancer
- Hepatocellular Carcinoma
- Pancreatic Cancer
- Esophageal Cancer
- Ovarian Epithelial Cancer
- Glioblastoma Multiforme
- Gastric Adenocarcinoma
- Triple Negative Breast Cancer
- Endometrial Cancer
- Non-small Cell Lung Cancer
- Renal Cell Cancer
- Carcinoma Breast Stage IV
- Hormone-refractory Prostate Cancer
- Head and Neck Cancers- Squamous Cell
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 080045
- University of Colorado Anschutz Medical Campus
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University School Of Medicine
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Delaware
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Newark, Delaware, United States, 19713
- Helen F. Graham Cancer Center
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Florida
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Orlando, Florida, United States, 32806
- MD Anderson Cancer Center Orlando (UF Health Cancer Center)
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Indiana
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Goshen, Indiana, United States, 46526
- IU Health Goshen Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusettes General Hospital
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New York
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New York, New York, United States, 10021
- Weill Cornell/New York Presbyterian Hospital
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New York, New York, United States, 10032
- Columbia University Herbert Irving Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, United States, 75246
- Texas Oncology Sammons Cancer Center
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Washington
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Seattle, Washington, United States, 98111
- Virginia Mason Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals able to understand and give written informed consent.
Histologically or cytologically confirmed epithelial cancer of one of the following types:
- Gastric adenocarcinoma (GC)
- Esophageal cancer (EC)
- Hepatocellular carcinoma (HCC)
- Non-small-cell lung cancer (NSCLC)
- Small-cell lung cancer (SCLC)
- Epithelial ovarian cancer (EOC)
- Cervical Cancer
- Endometrial Cancer
- Triple-negative breast cancer (TNBC)
- Non-triple-negative breast cancer
- Papillary thyroid cancer (excludes follicular, medullary, Hurthle cell, and anaplastic thyroid cancer)
- Glioblastoma multiforme (GBM)
- Hormone-refractory prostate cancer (HRPC)
- Head and neck cancers- squamous cell (SCCHN)
- Renal cell cancer (clear cell) (RCC)
- Urothelial cancer
- Stage IV (metastatic) disease (except for individuals with GBM).
- Refractory to or relapsed after at least one prior standard therapeutic regimen
- Adequate performance status (ECOG 0 or 1)
- Expected survival ≥ 6 months.
- Measurable disease by CT or MRI.
- At least 2 weeks beyond treatment (chemotherapy, investigational drugs including small molecular inhibitors, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities to Grade 1 or less (except alopecia).
- At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
- Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
- Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
- Otherwise, all toxicity at study entry ≤ Grade 1.
Exclusion Criteria:
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
- Individuals with Gilbert's disease.
- Individuals with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (> 20 mg prednisone or equivalent) for at least 4 weeks.
- Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension). Individuals with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.
- Individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
- Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
- Individuals known to be HIV positive, hepatitis B positive, or hepatitis C positive.
- Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
- Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
- Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of study treatment.
- Infection requiring intravenous antibiotic use within 1 week.
- History of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI toxicity to prior irinotecan,
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sacituzumab Govitecan-hziy (SG) 8 mg/kg
Participants will receive sacituzumab govitecan-hziy (SG) 8 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
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Administered via intravenous (IV) infusion
Other Names:
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Experimental: SG 10 mg/kg
Participants will receive SG 10 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
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Administered via intravenous (IV) infusion
Other Names:
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Experimental: SG 12 mg/kg
Participants will receive SG 12 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
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Administered via intravenous (IV) infusion
Other Names:
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Experimental: SG 18 mg/kg
Participants will receive SG 18 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
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Administered via intravenous (IV) infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Time Frame: First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days
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Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:
Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population. |
First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days
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Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death
Time Frame: First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
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Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
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First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
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Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events
Time Frame: First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
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Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
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First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
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Objective Response Rate (ORR) by Independent Central Review (ICR)
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1.
CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to <10 mm.
PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters.
Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Objective Response Rate by Local Assessment
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment.
CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to <10 mm.
PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters.
Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response by ICR
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Duration of Response by Local Assessment
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Per planned analysis, duration of response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Time to Response by ICR
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Time to response was defined as the time from the first dose to the first documentation of response (PR or CR).
Per planned analysis, time to response by ICR was assessed for the TNBC Target Population only.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Time to Response by Local Assessments
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Time to response was defined as the time from the first dose to the first documentation of response (PR or CR).
Per planned analysis, time to response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Clinical Benefit Rate (CBR) by Local Assessment
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Clinical benefit rate (CR+PR+[stable disease (SD) ≥ 6 months]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months.
SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier.
Per planned analysis, CBR by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Progression Free Survival (PFS) by Local Assessment
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
Per planned analysis, PFS by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Overall Survival by Local Assessment
Time Frame: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause.
Per planned analysis, overall survival by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
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Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Pharmacokinetic (PK) Parameter: T1/2 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Time Frame: Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hours (± 30 minutes) for subsequent infusions
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T1/2 was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration.
SN-38 is one of the components of sacituzumab govitecan-hziy.
T1/2 is defined as apparent terminal elimination half-life (h); calculated as 0.693/λz.
The dose level evaluated for PK analysis was 10 mg/kg.
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Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hours (± 30 minutes) for subsequent infusions
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PK Parameter: AUC0-24 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Time Frame: Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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AUC0-24 was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration.
SN-38 is one of the components of sacituzumab govitecan-hziy.
AUC0-24 is defined as area under the serum concentration-time curve from time 0 to 24 hours.
The dose level evaluated for PK analysis was 10 mg/kg.
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Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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PK Parameter: AUC0-168 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Time Frame: Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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AUC0-168 was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration.
SN-38 is one of the components of sacituzumab govitecan-hziy.
AUC0-168 is defined as area under the serum concentration-time curve from time 0 to 168 hours.
The dose level evaluated for PK analysis was 10 mg/kg.
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Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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PK Parameter: AUC0-inf of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Time Frame: Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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AUC0-inf was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration.
SN-38 is one of the components of sacituzumab govitecan-hziy.
AUC0-inf is defined as area under the serum concentration-time curve from time 0 extrapolated to infinity.
The dose level evaluated for PK analysis was 10 mg/kg.
|
Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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PK Parameter: Cmax of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Time Frame: Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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Cmax was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration.
SN-38 is one of the components of sacituzumab govitecan-hziy.
Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data.
The dose level evaluated for PK analysis was 10 mg/kg.
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Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12. Review.
- Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.
- Santin AD, Komiya T, Goldenberg DM, et al. Sacituzumab govitecan (SG) in patients (pts) with previously treated metastatic endometrial cancer (mEC): results from a phase 1/2 study. J Clin Oncol. 2020; 38 (suppl; abstr 6081)
- Bardia A, Mayer IA, Kalinsky K. Sacituzumab Govitecan-hziy in Triple-Negative Breast Cancer. Reply. N Engl J Med. 2019 Jun 13;380(24):2382. doi: 10.1056/NEJMc1903943. No abstract available.
- Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.
- Tagawa ST, Faltas M, Lam ET, et al. Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study. J Clin Oncol. 2019;39(suppl 7S):abstr 354.
- Bardia A, Diamond JR, Vahdat LT, et al. Efficacy of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for treatment-refractory hormone-receptor positive (HR+)/HER2- metastatic breast cancer (mBC). J Clin Oncol. 2018;36(15 suppl):1004.
- Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, Purcell WT, Guarino MJ, Misleh J, Schneider CJ, Schneider BJ, Ocean A, Johnson T, Gandhi L, Kalinsky K, Scheff R, Messersmith WA, Govindan SV, Maliakal PP, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM. Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res. 2017 Oct 1;23(19):5711-5719. doi: 10.1158/1078-0432.CCR-17-0933. Epub 2017 Jul 5.
- Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, Messersmith WA, Picozzi VJ, Mayer IA, Wegener WA, Maliakal P, Govindan SV, Sharkey RM, Goldenberg DM. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer. 2017 Oct 1;123(19):3843-3854. doi: 10.1002/cncr.30789. Epub 2017 May 30.
- Heist RS, Guarino MJ, Masters G, Purcell WT, Starodub AN, Horn L, Scheff RJ, Bardia A, Messersmith WA, Berlin J, Ocean AJ, Govindan SV, Maliakal P, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM, Camidge DR. Therapy of Advanced Non-Small-Cell Lung Cancer With an SN-38-Anti-Trop-2 Drug Conjugate, Sacituzumab Govitecan. J Clin Oncol. 2017 Aug 20;35(24):2790-2797. doi: 10.1200/JCO.2016.72.1894. Epub 2017 May 26.
- Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, Shah NC, O'Shaughnessy J, Kalinsky K, Guarino M, Abramson V, Juric D, Tolaney SM, Berlin J, Messersmith WA, Ocean AJ, Wegener WA, Maliakal P, Sharkey RM, Govindan SV, Goldenberg DM, Vahdat LT. Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2017 Jul 1;35(19):2141-2148. doi: 10.1200/JCO.2016.70.8297. Epub 2017 Mar 14.
- Sharkey RM, McBride WJ, Cardillo TM, Govindan SV, Wang Y, Rossi EA, Chang CH, Goldenberg DM. Enhanced Delivery of SN-38 to Human Tumor Xenografts with an Anti-Trop-2-SN-38 Antibody Conjugate (Sacituzumab Govitecan). Clin Cancer Res. 2015 Nov 15;21(22):5131-8. doi: 10.1158/1078-0432.CCR-15-0670. Epub 2015 Jun 23.
- Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Clin Cancer Res. 2015 Sep 1;21(17):3870-8. doi: 10.1158/1078-0432.CCR-14-3321. Epub 2015 May 5.
- Bardia A, Messersmith WA, Kio EA, Berlin JD, Vahdat L, Masters GA, Moroose R, Santin AD, Kalinsky K, Picozzi V, O'Shaughnessy J, Gray JE, Komiya T, Lang JM, Chang JC, Starodub A, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Wegener WA, Goswami T, Ocean AJ. Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial. Ann Oncol. 2021 Jun;32(6):746-756. doi: 10.1016/j.annonc.2021.03.005. Epub 2021 Mar 16.
- Faltas B, Goldenberg DM, Ocean AJ, Govindan SV, Wilhelm F, Sharkey RM, Hajdenberg J, Hodes G, Nanus DM, Tagawa ST. Sacituzumab Govitecan, a Novel Antibody--Drug Conjugate, in Patients With Metastatic Platinum-Resistant Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):e75-9. doi: 10.1016/j.clgc.2015.10.002. Epub 2015 Oct 19.
- Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, Rossi EA, Chang CH, Goldenberg DM. Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Bioconjug Chem. 2015 May 20;26(5):919-31. doi: 10.1021/acs.bioconjchem.5b00223. Epub 2015 May 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Ovarian Neoplasms
- Carcinoma, Renal Cell
- Breast Neoplasms
- Lung Neoplasms
- Carcinoma
- Glioblastoma
- Urinary Bladder Neoplasms
- Endometrial Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Ovarian Epithelial
- Triple Negative Breast Neoplasms
Other Study ID Numbers
- IMMU-132-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on Sacituzumab Govitecan-hziy (SG)
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Georgetown UniversityGilead SciencesRecruitingThymic Carcinoma | ThymomaUnited States
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Gilead SciencesActive, not recruitingNon-Small Cell Lung CancerUnited States, Belgium, Spain, United Kingdom, Australia, Japan, Italy, France, Israel, Netherlands, Puerto Rico, Portugal, Greece, Brazil, Poland, Canada, Austria, Germany, Mexico, Turkey
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Gilead SciencesRecruitingLiver Failure | Advanced or Metastatic Solid TumorFrance, United States
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University Hospital HeidelbergNot yet recruitingMetastatic Colorectal CancerGermany
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Gilead SciencesParexel; IQVIA RDS (Shanghai) Co., Ltd.; Medidata Solutions; Q Squared Solutions...Active, not recruitingMetastatic Triple-negative Breast CancerChina
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Veru Inc.WithdrawnMetastatic Triple Negative Breast Cancer
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Gilead SciencesActive, not recruitingMetastatic Solid TumorUnited States, Spain, France, Hong Kong, Australia, Belgium, Taiwan, Canada
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Gilead SciencesRecruiting
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Gilead SciencesRecruitingStudy of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors (ASCENT-J02)Advanced Solid Tumor | Metastatic Urothelial Cancer | Metastatic Triple-Negative Breast Cancer | HR+/HER2- Metastatic Breast CancerJapan
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Dana-Farber Cancer InstituteGilead SciencesActive, not recruitingBladder Cancer | Urothelial Cancer | Metastatic Urothelial Carcinoma | Metastatic Urothelial Carcinoma of the Renal Pelvis and UreterUnited States