Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
- Conditions
- Advanced or Metastatic Solid TumorLiver Failure
- Interventions
- Registration Number
- NCT04617522
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Advanced or Metastatic Solid Tumor and Moderate Liver Impairment Sacituzumab Govitecan-hziy 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). Advanced or Metastatic Solid Tumor and Normal Liver function Sacituzumab Govitecan-hziy 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).
- Primary Outcome Measures
Name Time Method 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 Days 1 and 8 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.
PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziy Days 1 and 8 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.
Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies Day 1 (Predose) and Day 22
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
NEXT Austin
🇺🇸Austin, Texas, United States
Oncology Consultants, P.A.
🇺🇸Houston, Texas, United States
The University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
Institut Bergonie Medical Oncology
🇫🇷Bordeaux, France
Centre Leon Berard
🇫🇷Lyon, France