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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501508-82 | Other Identifier | EU CT Number |
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The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced or Metastatic Solid Tumor and Moderate Liver Impairment | Experimental | Participants with advanced solid tumor and moderate hepatic impairment will receive an escalating dose of sacituzumab govitecan-hziy on Days 1 and 8. The dose-escalation plan will start at 5 mg/kg and escalate to 7.5 mg/kg, and finally 10 mg/kg, if deemed to be safe. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198). |
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| Advanced or Metastatic Solid Tumor and Normal Liver function | Experimental | Participants with advanced or metastatic solid tumor and normal hepatic function will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan-hziy | Drug | Administered intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs | First dose date up to Day 38 | |
| Percentage of Participants Experiencing Any Dose Limiting Toxicities (DLTs) | Up to Day 22 (for participants receiving SG on Day 1); Up to Day 28 (for participants receiving SG on Day 8) | |
| Percentage of Participants Experiencing Any Clinically Significant Laboratory Abnormalities | First dose date up to Day 38 | |
| Pharmacokinetic (PK) Parameter: Cmax of Free SN-38 and Sacituzumab Govitecan-hziy | Cmax will be determined for 2 analytes: 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 the maximum observed concentration obtained directly from the observed concentration-time data. | Days 1 and 8 |
| PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziy | AUC 0-168 will be determined for 2 analytes: 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. | Days 1 and 8 |
| Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies | Day 1 (Predose) and Day 22 |
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Key Inclusion Criteria for all Individuals:
Key Inclusion Criteria for Individuals with Normal Hepatic Function:
Key Inclusion Criteria for Individuals with Moderate Hepatic Function:
Key Exclusion Criteria for all Individuals:
Key Exclusion Criteria for Individuals with Normal Hepatic Impairment:
Key Exclusion Criteria for Individuals with Moderate Hepatic Impairment:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Shores Medical Group | Suspended | Long Beach | California | 90813 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21372224 | Background | Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Goldenberg DM. Humanized anti-Trop-2 IgG-SN-38 conjugate for effective treatment of diverse epithelial cancers: preclinical studies in human cancer xenograft models and monkeys. Clin Cancer Res. 2011 May 15;17(10):3157-69. doi: 10.1158/1078-0432.CCR-10-2939. Epub 2011 Mar 3. | |
| 25915780 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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|
| Christiana Care Health Services |
| Recruiting |
| Newark |
| Delaware |
| 19713 |
| United States |
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
| NEXT Austin | Withdrawn | Austin | Texas | 78758 | United States |
| Oncology Consultants, P.A. | Recruiting | Houston | Texas | 77030 | United States |
| The University of Texas M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Texas Liver Institute | Recruiting | San Antonio | Texas | 78215 | United States |
| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
| Institut Bergonie Medical Oncology | Recruiting | Bordeaux | 33000 | France |
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
| Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain | Recruiting | Saint-Herblain | France |
| Instituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Recruiting | Naples | 80131 | Italy |
| Institut Català d'Oncologia - L'Hospitalet de Llobregat | Recruiting | Barcelona | 08908 | Spain |
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
| 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. |
| 28069724 | Background | Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast Cancer. Clin Cancer Res. 2017 Jul 1;23(13):3405-3415. doi: 10.1158/1078-0432.CCR-16-2401. Epub 2017 Jan 9. |
| 26101915 | Background | Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015 Sep 8;6(26):22496-512. doi: 10.18632/oncotarget.4318. |
| 1244564 | Background | Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580. |
| 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. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
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