Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

NCT03964727 | Active Not Recruiting Phase 2 Results FDA Drug

• 3 other identifiers: IMMU-132-112019-000579-182024-513611-28
• Study Type: interventional
• Target: 227
• Locations: 8 countries
• Sites: 65

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.

Conditions

Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment

  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.

  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 Outcomes (17)

• ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment

  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

• Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment

  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

• Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment

  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

• Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment

  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

• DOR According to RECIST 1.1 by Investigator's Assessment

  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

Study Arms (6)

Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]

EXPERIMENTAL

Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression will receive sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Drug: Sacituzumab Govitecan-hziy

Cohort 1 Group 2: NSCLC (Adenocarcinoma)

EXPERIMENTAL

Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Drug: Sacituzumab Govitecan-hziy

Cohort 1 Group 3: NSCLC (SCC)

EXPERIMENTAL

Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Drug: Sacituzumab Govitecan-hziy

Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)

EXPERIMENTAL

Participants with HNSCC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Drug: Sacituzumab Govitecan-hziy

Cohort 3: Endometrial Cancer (EC)

EXPERIMENTAL

Participants with EC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Drug: Sacituzumab Govitecan-hziy

Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

EXPERIMENTAL

Participants with ES-SCLC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.

Drug: Sacituzumab Govitecan-hziy

Interventions

Sacituzumab Govitecan-hziy DRUG

Administered intravenously

Also known as: IMMU-132, GS-0132

Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]; Cohort 1 Group 2: NSCLC (Adenocarcinoma); Cohort 1 Group 3: NSCLC (SCC); Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC); Cohort 3: Endometrial Cancer (EC); Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (65)

Alaska Oncology & Hematology, LLC

Anchorage, Alaska, 99508, United States

Location

USOR - Arizona Oncology - Glendale - Saguaro Cancer Center

Glendale, Arizona, 85308, United States

Location

Arizona Oncology Associates PC-HAL

Goodyear, Arizona, 85395, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

UCLA Hematology/Oncology

Los Angeles, California, 90095, United States

Location

TRIO-US Central Administration

Whittier, California, 90602, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Smilow Cancer Hospital at Yale

New Haven, Connecticut, 06520, United States

Location

SIU School of Medicine, Simmons Cancer Institute at SIU

Springfield, Illinois, 62702, United States

Location

PathGroup Labs, LLC

Fort Wayne, Indiana, 46804, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Christus Highland Cancer Treatment Center

Shreveport, Louisiana, 71105, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

North Mississippi Medical Center - Hematology and Oncology - Tupelo

Tupelo, Mississippi, 38801, United States

Location

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

David C. Pratt Center

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer of Nevada

Las Vegas, Nevada, 89052, United States

Location

New York Oncology Hematology - Albany Medical Center

Albany, New York, 12208, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medicine - Upper East Side

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, 97401, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Blue Ridge Cancer Care - Wytheville

Blacksburg, Virginia, 24060, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Southern Highlands Cancer Center

Bowral, New South Wales, 2576, Australia

Location

Macquarie University

North Ryde, New South Wales, 2109, Australia

Location

Calvary Mater Newcastle Hospital

Waratah, New South Wales, 2298, Australia

Location

Blacktown Hospital

Westmead, New South Wales, 2145, Australia

Location

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

Location

Mater Cancer Centre, Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

Monash Medical Centre, Monash Health

Clayton, Victoria, 3168, Australia

Location

The Andrew Love Cancer Centre, Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Cliniques Universitaires UCL Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hopital de Charleroi asbl (GHdC)

Charleroi, 6000, Belgium

Location

Cross Cancer Institute

Edmonton, T6G 1Z2, Canada

Location

London Health Sciences Centre- Victoria Hospital

London, N6A 5W9, Canada

Location

Jewish General Hospital

Montreal, H3T 1E2, Canada

Location

The Ottawa Hospital

Ottawa, K1H 8L6, Canada

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Centre George Francois Leclerc

Dijon, 21000, France

Location

Institut Claudius Régaud - IUCT Oncopole

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Hong Kong Integrated Oncology Centre

Central, Hong Kong

Location

Hong Kong Sanatorium & Hospital

Happy Valley, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Hong Kong United Oncology Center

Kowloon, Hong Kong

Location

Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hong Kong

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Institut Català d'Oncologia

Barcelona, 08908, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Changhua Christian Hospital

Changhua, Taiwan

Location

Taipei TzuChi Hospital

New Taipei City, Taiwan

Location

Chi Mei Medical Center

Tainan, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Location

Related Publications (3)

• Santin AD, Corr BR, Spira A, Willmott L, Butrynski J, Tse KY, Patel J, Mekan S, Wu T, Lin KW, Kuo P, Dumbrava EE. Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer. J Clin Oncol. 2024 Oct 10;42(29):3421-3429. doi: 10.1200/JCO.23.02767. Epub 2024 Jul 31.

  PMID: 39083724 BACKGROUND

• Michel L, Jimeno A, Sukari A, Beck JT, Chiu J, Ahern E, Hilton J, Even C, Zanetta S, Mekan S, Patel J, Wu T, Dumbrava EE. Sacituzumab Govitecan in Patients with Relapsed/Refractory Advanced Head and Neck Squamous Cell Carcinoma: Results from the Phase II TROPiCS-03 Basket Study. Clin Cancer Res. 2025 Mar 3;31(5):832-838. doi: 10.1158/1078-0432.CCR-24-2523.

  PMID: 39665770 BACKGROUND

• Dowlati A, Chiang AC, Cervantes A, Babu S, Hamilton E, Wong SF, Tazbirkova A, Sullivan IG, van Marcke C, Italiano A, Patel J, Mekan S, Wu T, Waqar SN. Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03. J Thorac Oncol. 2025 Jun;20(6):799-808. doi: 10.1016/j.jtho.2024.12.028. Epub 2025 Jan 2.

  PMID: 39755168 BACKGROUND

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 28, 2019
• Study Start: October 15, 2019
• Primary Completion: January 15, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); ES (5); HK (5); CA (4); AU (9); BE (2); TW (5); US (31)