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Promising drug shrinks tumors in advanced cancers

NCT ID NCT03964727

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called sacituzumab govitecan in 227 people whose solid tumors had spread to other parts of the body. The main goal was to see if the drug could shrink tumors. Researchers measured how many patients had their tumors shrink or disappear. This is not a cure, but aims to control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

227 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

endometrial carcinoma head and neck squamous cell carcinoma metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic solid tumor

Contacts and locations

Locations

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska, 99508, United States

  • Arizona Oncology Associates PC-HAL

    Goodyear, Arizona, 85395, United States

  • Blacktown Hospital

    Westmead, New South Wales, 2145, Australia

  • Blue Ridge Cancer Care - Wytheville

    Blacksburg, Virginia, 24060, United States

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298, Australia

  • Centre George Francois Leclerc

    Dijon, 21000, France

  • Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33305, Taiwan

  • Changhua Christian Hospital

    Changhua, Taiwan

  • Chi Mei Medical Center

    Tainan, Taiwan

  • Christus Highland Cancer Treatment Center

    Shreveport, Louisiana, 71105, United States

  • Cliniques Universitaires UCL Saint-Luc

    Brussels, 1200, Belgium

  • Comprehensive Cancer of Nevada

    Las Vegas, Nevada, 89052, United States

  • Cross Cancer Institute

    Edmonton, T6G 1Z2, Canada

  • David C. Pratt Center

    St Louis, Missouri, 63141, United States

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

    Shatin, Hong Kong

  • Grand Hopital de Charleroi asbl (GHdC)

    Charleroi, 6000, Belgium

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hong Kong Integrated Oncology Centre

    Central, Hong Kong

  • Hong Kong Sanatorium & Hospital

    Happy Valley, Hong Kong

  • Hong Kong United Oncology Center

    Kowloon, Hong Kong

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Català d'Oncologia

    Barcelona, 08908, Spain

  • Institut Claudius Régaud - IUCT Oncopole

    Toulouse, 31059, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Jewish General Hospital

    Montreal, H3T 1E2, Canada

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • London Health Sciences Centre- Victoria Hospital

    London, N6A 5W9, Canada

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112, Australia

  • Macquarie University

    North Ryde, New South Wales, 2109, Australia

  • Mater Cancer Centre, Mater Misericordiae Limited

    South Brisbane, Queensland, 4101, Australia

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Monash Medical Centre, Monash Health

    Clayton, Victoria, 3168, Australia

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • New York Oncology Hematology - Albany Medical Center

    Albany, New York, 12208, United States

  • North Mississippi Medical Center - Hematology and Oncology - Tupelo

    Tupelo, Mississippi, 38801, United States

  • Parkview Research Center

    Fort Wayne, Indiana, 46845, United States

  • PathGroup Labs, LLC

    Fort Wayne, Indiana, 46804, United States

  • Pindara Private Hospital

    Benowa, Queensland, 4217, Australia

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201, United States

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • SIU School of Medicine, Simmons Cancer Institute at SIU

    Springfield, Illinois, 62702, United States

  • Smilow Cancer Hospital at Yale

    New Haven, Connecticut, 06520, United States

  • Southern Highlands Cancer Center

    Bowral, New South Wales, 2576, Australia

  • TRIO-US Central Administration

    Whittier, California, 90602, United States

  • Taipei TzuChi Hospital

    New Taipei City, Taiwan

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Tyler

    Tyler, Texas, 75702, United States

  • The Andrew Love Cancer Centre, Geelong Hospital

    Geelong, Victoria, 3220, Australia

  • The Ottawa Hospital

    Ottawa, K1H 8L6, Canada

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095, United States

  • USOR - Arizona Oncology - Glendale - Saguaro Cancer Center

    Glendale, Arizona, 85308, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine - Upper East Side

    New York, New York, 10065, United States

  • Willamette Valley Cancer Institute and Research Center - Eugene

    Eugene, Oregon, 97401, United States

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