BridgeMD
New treatment option for Advanced or Metastatic Solid Tumor
Official title Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
ClinicalTrials.gov ID: NCT04617522
What this study is testing
What is Sacituzumab Govitecan-hziy?
Sacituzumab Govitecan-hziy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced or metastatic solid tumor.
Also referred to as IMMU-132, GS-0132.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key for all Individuals:
- Histologically confirmed advanced or metastatic solid tumor that is measurable or nonmeasurable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute...
- Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation. Key for Individuals with Normal Hepatic Function:
You likely can't join if
- for all Individuals:
- Have poor venous access.
- Donated or lost 500mL or more of blood volume (including plasmapheresis) to plans to donate during the study.
- Have had a prior anticancer biologic agent within 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or...
- Had prior treatment with irinotecan within 4 weeks prior to Day 1.
- Have not recovered (i.e., ≤ Grade 1) from AEs due to a previously administered agent.
See the full eligibility criteria
- Key for all Individuals:
- Histologically confirmed advanced or metastatic solid tumor that is measurable or nonmeasurable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥1,500/mm\^3, and platelets ≥ 100,000/ μL).
- Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation. Key for Individuals with Normal Hepatic Function:
- Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase (AST) ≤ 3.0× ULN). Key for Individuals with Moderate Hepatic Function:
- Moderate hepatic impairment (1.5 × ULN \< total bilirubin ≤ 3.0 × ULN and any level of AST).
- For individuals with hepatic encephalopathy, the condition does not, in the Investigator's opinion, interfere with the individual's ability to provide an appropriate informed consent. Key
- for all Individuals:
- Have poor venous access.
- Donated or lost 500mL or more of blood volume (including plasmapheresis) to plans to donate during the study.
- Have had a prior anticancer biologic agent within 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 and who have not recovered...
- Had prior treatment with irinotecan within 4 weeks prior to Day 1.
- Have not recovered (i.e., ≤ Grade 1) from AEs due to a previously administered agent.
- Have an active second malignancy.
- Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks...
- Have history of cardiac disease.
- Have active chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
- Have active serious infection (Contact medical monitor for clarification).
- High-dose systemic corticosteroids (≥20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Check-In. However, inhaled, intranasal, intra-articular, and topical steroids are allowed.
- Use of strong inhibitor or inducer of UGT1A1.
- Have a known history of Gilbert's disease. Key Exclusion Criteria for Individuals with Normal Hepatic Impairment:
- Must have pre-existing condition interfering with hepatic and/or renal function that could interfere with the metabolism and/or excretion of the study drug. Key Exclusion Criteria for Individuals with Moderate Hepatic...
- Had a significant clinical exacerbation of liver disease symptoms within the 2-week period before administration of study drug (i.e., abdominal pain, nausea, vomiting, anorexia, or fever).
- Had clinically demonstrable, tense ascites.
- Had evidence of acute viral hepatitis within 1 month prior to administration of study drug.
- Have evidence of hepatorenal syndrome.
- Individuals with transjugular intrahepatic portosystemic shunt (TIPS) placement.
- Have active Stage 3 or 4 encephalopathy.
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Newark, Delaware, United States
- Baltimore, Maryland, United States
- Austin, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Bordeaux, France
- Lyon, France
- Saint-Herblain, France
- Milan, Italy
- Naples, Italy
- Barcelona, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Newark, Delaware, United States; Baltimore, Maryland, United States; Austin, Texas, United States; Houston, Texas, United States; San Antonio, Texas, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.