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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).
The outcome measures are planned to be assessed up to the data cutoff date. Following the data cutoff date, the participants will either stay on the study and will be followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data will be collected after the data cutoff date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan-hziy (SG) 8 mg/kg | Experimental | 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. |
|
| SG 10 mg/kg | Experimental | 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. |
|
| SG 12 mg/kg | Experimental | 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. |
|
| SG 18 mg/kg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan-hziy (SG) | Drug | Administered via intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | 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 |
| Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death | 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). | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) |
| Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events | 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). | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response by ICR | 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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Inclusion Criteria:
Individuals able to understand and give written informed consent.
Histologically or cytologically confirmed epithelial cancer of one of the following types:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 080045 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32946924 | Result | 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. | |
| Result | 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) | ||
| 31189049 |
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Tumor types included in the study were as follows: 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).
Participants were enrolled at study sites in the United States. The first participant was screened on 17 December 2012. The last study visit occurred on 13 August 2020.
Outcome Measures were assessed up to the data cutoff date of 01 March 2019. Following the data cutoff date, the participants either stayed on the study and were followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data was collected after the data cutoff date.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sacituzumab Govitecan-hziy (SG) 8 mg/kg | Participants received 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. |
| FG001 | SG 10 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2020 | Jan 7, 2021 |
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|
| Objective Response Rate (ORR) by Independent Central Review (ICR) | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Objective Response Rate by Local Assessment | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Duration of Response by Local Assessment | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Time to Response by ICR | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Time to Response by Local Assessments | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Clinical Benefit Rate (CBR) by Local Assessment | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Progression Free Survival (PFS) by Local Assessment | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Overall Survival by Local Assessment | 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. | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| Pharmacokinetic (PK) Parameter: T1/2 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | 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 |
| PK Parameter: AUC0-24 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | 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 |
| PK Parameter: AUC0-168 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | 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 |
| PK Parameter: AUC0-inf of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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 |
| PK Parameter: Cmax of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | 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 |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Helen F. Graham Cancer Center | Newark | Delaware | 19713 | United States |
| MD Anderson Cancer Center Orlando (UF Health Cancer Center) | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| IU Health Goshen Cancer Center | Goshen | Indiana | 46526 | United States |
| Massachusettes General Hospital | Boston | Massachusetts | 02114 | United States |
| Weill Cornell/New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Columbia University Herbert Irving Cancer Center | New York | New York | 10032 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37212 | United States |
| Texas Oncology Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Virginia Mason Cancer Center | Seattle | Washington | 98111 | United States |
| Result |
| 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. |
| 30786188 | Result | 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. |
| Result | 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. |
| Result | 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. |
| 28679770 | Result | 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. |
| 28558150 | Result | 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. |
| 28548889 | Result | 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. |
| 28291390 | Result | 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. |
| 26106073 | Result | 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. |
| 25944802 | Result | 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. |
| 35728046 | Derived | 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. |
| 33741442 | Derived | 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. |
| 26541586 | Derived | 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. |
| 25915780 | Derived | 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. |
Participants received sacituzumab govitecan-hziy 10 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. |
| FG002 | SG 12 mg/kg | Participants received sacituzumab govitecan-hziy 12 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. |
| FG003 | SG 18 mg/kg | Participants received sacituzumab govitecan-hziy 18 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. |
| Enrolled and Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SG 8mg/kg | Participants received sacituzumab govitecan-hziy 8 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. |
| BG001 | SG 10 mg/kg | Participants received sacituzumab govitecan-hziy 10 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. |
| BG002 | SG 12 mg/kg | Participants received sacituzumab govitecan-hziy 12 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. |
| BG003 | SG 18 mg/kg | Participants received sacituzumab govitecan-hziy 18 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | 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. |
| Posted | Number | Percentage of participants | 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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| Primary | Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death | 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). |
| Posted | Number | Percentage of participants | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events | 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). |
| Posted | Number | Percentage of participants | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) by Independent Central Review (ICR) | 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. | Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
|
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| Primary | Objective Response Rate by Local Assessment | 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. |
| Posted | Number | 95% Confidence Interval | Percentage of participants | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response by ICR | 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. | Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only. | Posted | Median | 95% Confidence Interval | months | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response by Local Assessment | 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. |
| Posted | Median | 95% Confidence Interval | months | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response by ICR | 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. | Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG | Posted | Median | Full Range | months | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
|
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| Secondary | Time to Response by Local Assessments | 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. |
| Posted | Median | Full Range | months | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) by Local Assessment | 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. |
| Posted | Number | 95% Confidence Interval | Percentage of participants | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) by Local Assessment | 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. |
| Posted | Median | 95% Confidence Interval | months | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival by Local Assessment | 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. |
| Posted | Median | 95% Confidence Interval | months | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Parameter: T1/2 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 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 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: AUC0-24 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per liter | 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 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: AUC0-168 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per liter | 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 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: AUC0-inf of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per liter | 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 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: Cmax of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38 | 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. | Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per liter | 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 |
|
Overall Safety Population: All participants who received at least 1 dose of SG. Per planned analysis, data were collected for the Overall Safety Population, pooling all participants regardless of dose level received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Safety Population | All participants who were enrolled in the study and received one dose of sacituzumab govitecan-hziy (SG) at dose level of either 8 mg/kg, 10 mg/kg, 12 mg/kg, or 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. | 422 | 495 | 192 | 495 | 490 | 495 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Purtscher retinopathy | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pouchitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vocal cord dysfunction | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraneoplastic dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Immunomedics, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2019 | Jan 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D001943 | Breast Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005909 | Glioblastoma |
| D064726 | Triple Negative Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D010182 | Pancreatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| Not Hispanic or Latino |
|
| Serious Adverse Events |
|
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population. |
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
| OG003 | Overall Safety Population (OSP) | Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety. |
|
|
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
| OG003 | Overall Safety Population (OSP) | Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety. |
|
|
|
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population. |
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
|
|
|
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population. |
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
|
|
|
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
|
|
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population. |
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
|
|
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
|
|
| OG002 | mUC Population | Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population. |
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