Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

Part of paid clinical trials in Long Beach, California.

Sponsor
Gilead Sciences
Study ID
NCT04617522
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced or Metastatic Solid Tumor
  • Liver Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan-hziy — DRUG
    Administered intravenously

Study Details

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.

Key Dates

Start date
Apr 6, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
    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).
  • Experimental: Advanced or Metastatic Solid Tumor and Normal Liver function
    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 Measure

Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs [ Time Frame: First dose date up to Day 38 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Pacific Shores Medical GroupLong BeachCalifornia90813-
Christiana Care Health ServicesNewarkDelaware19713-
University of MarylandBaltimoreMaryland21201-
NEXT AustinAustinTexas78758-
Oncology Consultants, P.A.HoustonTexas77030-
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-
NEXT OncologySan AntonioTexas78229-
Texas Liver InstituteSan AntonioTexas78215-

Find similar trials in Long Beach, CA

By research site
Pacific Shores Medical Group· Long Beach, CAChristiana Care Health Services· Newark, DEUniversity of Maryland· Baltimore, MDNEXT Austin· Austin, TXOncology Consultants, P.A.· Houston, TXThe University of Texas M.D. Anderson Cancer Center· Houston, TX

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