Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

Conditions
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Metastatic Solid Tumor

Intervention / Treatment
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* Drug: Sacituzumab Govitecan-hziy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacituzumab Govitecan-hziy<br>Participants with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer, or metastatic small cell lung cancer (mSCLC) will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent. | Drug: Sacituzumab Govitecan-hziy<br>* Administered intravenously<br>* Other names: GS-0132;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | 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. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment | 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. | Up to 3 years | 
| Duration of Response (DOR) According to RECIST 1.1 by BICR | 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 | Up to 3 years | 
| Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR | 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. | Up to 3 years | 
| Progression-free Survival (PFS) According to RECIST 1.1 by BICR | 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 | Up to 3 years | 
| DOR According to RECIST 1.1 by Investigator's Assessment | 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. | Up to 3 years | 
| Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment | 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. | Up to 3 years | 
| Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment | 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. | Up to 3 years | 
| Overall Survival (OS) | Overall survival is defined as the interval from the first dose date of drug to death from any cause. | Up to 3 years | 
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) |  | Up to 3 years | 
| Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities |  | Up to 3 years | 
| Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy |  | First dose date up to last dose date plus 30 days (up to 3 years) | 
| Immunogenicity Assessment | Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported. | First dose date up to last dose date plus 30 days (up to 3 years) |