A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Summary
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.
Arms & interventions
- DrugSacituzumab Govitecan-hziy
Administered intravenously
Outcome measures
Primary
Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs
Time frame: First dose date up to Day 38
Percentage of Participants Experiencing Any Dose Limiting Toxicities (DLTs)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Days 1 and 8
Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies
Time frame: Day 1 (Predose) and Day 22
Eligibility criteria
Study locations (8)
Pacific Shores Medical Group
Long Beach, California, 90813
Christiana Care Health Services
Newark, Delaware, 19713
University of Maryland
Baltimore, Maryland, 21201
NEXT Austin
Austin, Texas, 78758
Oncology Consultants, P.A.
Houston, Texas, 77030
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Texas Liver Institute
San Antonio, Texas, 78215
NEXT Oncology
San Antonio, Texas, 78229
References
- 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.(PubMed)
- 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.(PubMed)
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- 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.(PubMed)
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- 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.(PubMed)