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).
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Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Timeframe: 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
Timeframe: 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
Timeframe: First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
Objective Response Rate (ORR) by Independent Central Review (ICR)
Timeframe: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Objective Response Rate by Local Assessment
Timeframe: Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)