Brief Summary
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.
Brief Title
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Metastatic Solid Tumor
Eligibility Criteria
Key Inclusion Criteria:
* Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
* NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
* HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
* Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
* Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
* Adequate hepatic and renal function (CrCl ≥30mL/min)
* Individual must have at least a 3-month life expectancy
* Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Key Exclusion Criteria:
* Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1
* Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
* Have previously received topoisomerase I inhibitors
* 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
* Additional cohort specific exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
* Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
* NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
* HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
* Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
* Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
* Adequate hepatic and renal function (CrCl ≥30mL/min)
* Individual must have at least a 3-month life expectancy
* Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Key Exclusion Criteria:
* Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1
* Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
* Have previously received topoisomerase I inhibitors
* 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
* Additional cohort specific exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria:
* Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
* NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
* HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
* Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
* Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
* Adequate hepatic and renal function (CrCl ≥30mL/min)
* Individual must have at least a 3-month life expectancy
* Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Inclusion/
* Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
* NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
* HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
* Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
* Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
* Adequate hepatic and renal function (CrCl ≥30mL/min)
* Individual must have at least a 3-month life expectancy
* Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03964727
Org Class
Industry
Org Full Name
Gilead Sciences
Org Study Id
IMMU-132-11
Overall Status
Active, not recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Primary Outcomes
Outcome Description
ORR, is defined as the proportion of participants who achieve the best overall response, confirmed complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
Outcome Measure
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Outcome Time Frame
Up to 3 years
Secondary Ids
Secondary Id
2019-000579-18
Secondary Id
2024-513611-28
Secondary Outcomes
Outcome Description
ORR, is defined as the proportion of participants who achieve the best overall response, confirmed CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria.
Outcome Time Frame
Up to 3 years
Outcome Measure
Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
Outcome Description
DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first progression of disease (PD) or death from any cause, whichever comes first. Response are according to RECIST 1.1 by BICR
Outcome Time Frame
Up to 3 years
Outcome Measure
Duration of Response (DOR) According to RECIST 1.1 by BICR
Outcome Description
CBR is defined as the proportion of participants who achieve the best overall response, CR + PR + stable disease (SD). Responses are according to RECIST 1.1 by BICR.
Outcome Time Frame
Up to 3 years
Outcome Measure
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR
Outcome Description
PFS, is defined as the time from first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR
Outcome Time Frame
Up to 3 years
Outcome Measure
Progression-free Survival (PFS) According to RECIST 1.1 by BICR
Outcome Description
DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first PD or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
Outcome Time Frame
Up to 3 years
Outcome Measure
DOR According to RECIST 1.1 by Investigator's Assessment
Outcome Description
CBR, is defined as the proportion of participants who achieve the best overall response, CR + PR + SD. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
Outcome Time Frame
Up to 3 years
Outcome Measure
Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment
Outcome Description
PFS, is defined as the time from first dose until objective tumor progression or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
Outcome Time Frame
Up to 3 years
Outcome Measure
Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment
Outcome Description
Overall survival is defined as the interval from the first dose date of drug to death from any cause.
Outcome Time Frame
Up to 3 years
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Up to 3 years
Outcome Measure
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Outcome Time Frame
Up to 3 years
Outcome Measure
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Outcome Time Frame
First dose date up to last dose date plus 30 days (up to 3 years)
Outcome Measure
Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy
Outcome Description
Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported.
Outcome Time Frame
First dose date up to last dose date plus 30 days (up to 3 years)
Outcome Measure
Immunogenicity Assessment
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Nevadunsky
Investigator Email
nnevadun@montefiore.org
Investigator Phone
718-405-8082
Categories Mesh Debug
Cancer --- NEOPLASMS
MeSH Terms
NEOPLASM METASTASIS
NEOPLASTIC PROCESSES
NEOPLASMS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
SACITUZUMAB GOVITECAN