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 \[adenocarcinoma or squamous cell carcinoma (SCC)\] 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 \[Creatinine Clearance (CrCl) ≥30mL/min\]
* 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 \[adenocarcinoma or squamous cell carcinoma (SCC)\] 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 \[Creatinine Clearance (CrCl) ≥30mL/min\]
* 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 \[adenocarcinoma or squamous cell carcinoma (SCC)\] 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 \[Creatinine Clearance (CrCl) ≥30mL/min\]
* 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 \[adenocarcinoma or squamous cell carcinoma (SCC)\] 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 \[Creatinine Clearance (CrCl) ≥30mL/min\]
* 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 was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. Percentages are rounded off.
Outcome Measure
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Secondary Ids
Secondary Id
2019-000579-18
Secondary Id
2024-513611-28
Secondary Outcomes
Outcome Description
ORR was defined as the percentage of participants who had the best overall response of either CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
Outcome Description
DOR was the date of the first evaluation showing documented response, either PR or CR, to 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 for each histological cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR: \>30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment
Outcome Description
CBR was percentage of participants with best overall response of CR, PR,or durable stable disease (SD) (SD ≥ 6 months after first dose). Responses are according to RECIST 1.1 by BICR.CR: Disappearance of all target and non-target lesions;\& normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD, taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of \>20% in sum of diameters of target lesions, taking reference of smallest sum(this includes baseline sum if smallest on study), the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. Two-sided CI was based on Clopper-Pearson method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment
Outcome Description
PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment
Outcome Description
DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first PD or death from any cause, whichever comes first. Responses are based on investigator-assessed tumor response by RECIST 1.1 criteria for each histological cohort.CR:Disappearance of all target and non-target lesions;and normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in the sum of the LD of target lesions,taking as reference the baseline sum LD. Disease progression was defined as increase of \>20% in sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study).In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
DOR According to RECIST 1.1 by Investigator's Assessment
Outcome Description
CBR was the percentage of participants with the best overall response of CR, PR,or durable SD (SD ≥ 6 months after first dose) by investigator-assessed tumor response using RECIST 1.1 criteria.CR:Disappearance of all target and non-target lesions;\& normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in sum of LD of target lesions,taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD,taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of \>20% in sum of diameters of target lesions,taking reference of smallest sum(this includes baseline sum if smallest on study),the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions.Two-sided CI was based on Clopper-Pearson method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
CBR According to RECIST 1.1 by Investigator's Assessment
Outcome Description
PFS was defined as the time from the 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. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
PFS According to RECIST 1.1 by Investigator's Assessment
Outcome Description
OS was defined as the interval from the first dose date of drug to death from any cause. OS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Outcome Time Frame
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Outcome Measure
Overall Survival (OS)
Outcome Description
A TEAE was defined as any AE with an onset date on or after the study drug start date and no later than 30 days after last dose of study drug or the day before initiation of subsequent therapy, whichever comes first.
Outcome Time Frame
Up to 7.2 years
Outcome Measure
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Outcome Description
A treatment-emergent laboratory abnormality was defined as any value that increased at least 1 toxicity grade from baseline during the treatment-emergent period.
Outcome Time Frame
Up to 7.2 years
Outcome Measure
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Outcome Description
Cmax was defined as the maximum observed concentration of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
Outcome Time Frame
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
Outcome Measure
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Outcome Description
Cmax was defined as the maximum observed concentration of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
Outcome Time Frame
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
Outcome Measure
PK Parameter: Cmax of Free SN-38
Outcome Description
Cmax was defined as the maximum observed concentration of total antibody of SG \[hRS7 immunoglobulin (IgG) and hRS7-SN-38\]. Cycle length=21 days.
Outcome Time Frame
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
Outcome Measure
PK Parameter: Cmax of Total Antibody
Outcome Description
Ctrough was defined as concentration at the end of the dosing interval of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy).
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome Time Frame
C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU
Outcome Measure
PK Parameter: Ctrough of Total SN-38
Outcome Description
Ctrough was defined as concentration at the end of the dosing interval of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy).
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome Time Frame
C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU
Outcome Measure
PK Parameter: Ctrough of Free SN-38
Outcome Description
Ctrough was defined as concentration at the end of the dosing interval of total antibody of SG \[hRS7 immunoglobulin (IgG) and hRS7-SN-38\].
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome Time Frame
C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU
Outcome Measure
PK Parameter: Ctrough of Total Antibody
Outcome Description
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
Outcome Time Frame
C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU
Outcome Measure
Percentage of Participants With Positive Anti-SG Antibodies
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