Description:
The primary objectives of this study are to identify the safe starting dose of sacituzumab
govitecan-hziy, assess the number of participants with antibodies against sacituzumab
govitecan-hziy, and evaluate the pharmacokinetics (PK) of sacituzumab govitecan-hziy, free
SN-38, SN-38 glucuronide (SN-38G), total SN-38, in participants with solid tumor and moderate
hepatic impairment.
Title
- Brief Title: Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan-hziy in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
IMMU-132-15
- NCT ID:
NCT04617522
Conditions
- Advanced or Metastatic Solid Tumor
- Liver Failure
Interventions
Drug | Synonyms | Arms |
---|
Sacituzumab Govitecan-hziy | IMMU-132 | Advanced or Metastatic Solid Tumor and Moderate Liver Impairment |
Purpose
The primary objectives of this study are to identify the safe starting dose of sacituzumab
govitecan-hziy, assess the number of participants with antibodies against sacituzumab
govitecan-hziy, and evaluate the pharmacokinetics (PK) of sacituzumab govitecan-hziy, free
SN-38, SN-38 glucuronide (SN-38G), total SN-38, in participants with solid tumor and moderate
hepatic impairment.
Trial Arms
Name | Type | Description | Interventions |
---|
Advanced or Metastatic Solid Tumor and Moderate Liver Impairment | Experimental | 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). | - Sacituzumab Govitecan-hziy
|
Advanced or Metastatic Solid Tumor and Normal Liver function | Experimental | 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). | - Sacituzumab Govitecan-hziy
|
Eligibility Criteria
Key Inclusion Criteria 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 Inclusion Criteria for Individuals with Normal Hepatic Function:
- Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase [AST] ≤
3.0× ULN).
Key Inclusion Criteria 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 Exclusion Criteria 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 (i.e., ≤ Grade 2) from adverse events
(AEs) at the time of study entry. Individuals participating in observational studies
are eligible.
- 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 prior to the first dose of
study drug and all neurologic symptoms have returned to baseline, have no evidence of
new or enlarging brain metastases, and are taking ≤ 20 mg/day of prednisone or its
equivalent. All individuals with carcinomatous meningitis are excluded regardless of
clinical stability.
- 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 requiring intravenous antibiotics (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 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 Impairment:
- Had a clinical exacerbation of liver disease 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) |
Time Frame: | First dose date up to Day 38 |
Safety Issue: | |
Description: | Cmax will be determined for 4 analytes: Free SN-38, SN-38 glucuronide, Total 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Gilead Sciences |
Last Updated
August 18, 2021