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Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

Phase 2
Active, not recruiting
Conditions
Metastatic Solid Tumor
Interventions
Registration Number
NCT03964727
Lead Sponsor
Gilead Sciences
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
227
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Sacituzumab Govitecan-hziySacituzumab Govitecan-hziyParticipants 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.
Primary Outcome Measures
NameTimeMethod
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's AssessmentUp to 3 years

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.

Secondary Outcome Measures
NameTimeMethod
Duration of Response (DOR) According to RECIST 1.1 by BICRUp to 3 years

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

Progression-free Survival (PFS) According to RECIST 1.1 by BICRUp to 3 years

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

Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICRUp to 3 years

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.

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)Up to 3 years
DOR According to RECIST 1.1 by Investigator's AssessmentUp to 3 years

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.

Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) AssessmentUp to 3 years

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.

Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's AssessmentUp to 3 years

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.

Overall Survival (OS)Up to 3 years

Overall survival is defined as the interval from the first dose date of drug to death from any cause.

Percentage of Participants Experiencing Clinically Significant Laboratory AbnormalitiesUp to 3 years
Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's AssessmentUp to 3 years

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.

Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziyFirst dose date up to last dose date plus 30 days (up to 3 years)
Immunogenicity AssessmentFirst dose date up to last dose date plus 30 days (up to 3 years)

Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported.

Trial Locations

Locations (65)

Alaska Oncology & Hematology, LLC

🇺🇸

Anchorage, Alaska, United States

USOR - Arizona Oncology - Glendale - Saguaro Cancer Center

🇺🇸

Glendale, Arizona, United States

Arizona Oncology Associates PC-HAL

🇺🇸

Goodyear, Arizona, United States

Highlands Oncology Group

🇺🇸

Springdale, Arkansas, United States

UCLA Hematology/Oncology

🇺🇸

Los Angeles, California, United States

TRIO-US Central Administration

🇺🇸

Whittier, California, United States

University of Colorado Hospital - Anschutz Cancer Pavilion

🇺🇸

Aurora, Colorado, United States

Smilow Cancer Hospital at Yale

🇺🇸

New Haven, Connecticut, United States

SIU School of Medicine, Simmons Cancer Institute at SIU

🇺🇸

Springfield, Illinois, United States

PathGroup Labs, LLC

🇺🇸

Fort Wayne, Indiana, United States

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Alaska Oncology & Hematology, LLC
🇺🇸Anchorage, Alaska, United States
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