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New drug targets Hard-to-Treat cancers in japanese patients

NCT ID NCT05101096

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tests a drug called sacituzumab govitecan (Trodelvy) in Japanese patients with advanced solid tumors, including certain breast and bladder cancers. The trial has two phases: first, to find the safest dose, and second, to see how well the drug shrinks tumors. Participants receive the drug intravenously and are monitored for side effects and response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacituzumab govitecan (Trodelvy)
What this could lead to
If successful, this could provide a new treatment option for Japanese patients with certain advanced solid tumors that are hard to treat.
What could go wrong
This is an early-phase study, so the drug may not work as hoped or could cause significant side effects. Results may not apply to all populations.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

135 people

The number who actually took part.

Started

Oct 2021

Expected to finish

May 2027

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: * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria * Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation * Adequate hepatic function (bilirubin ≤ 1.5 upper limit of normal (ULN)), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN * Creatinine clearance ≥ 30 mL/min * Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Phase 1 only: Histologically or cytologically confirmed advanced solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. * Phase 2 metastatic triple-negative breast cancer (mTNBC) Cohort: Histologically or cytologically confirmed TNBC per American Society of Clinical Oncologists/College of American Pathologists (ASCO/CAP) criteria, based on the most recent analyzed biopsy or other pathology specimen. Refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer. * Phase 2 hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2- mBC) Cohort: Documented evidence of HR+/HER2- mBC confirmed by a local laboratory and defined per ASCO/CAP criteria. * Refractory to or relapsed after 2 prior systemic chemotherapy regimens for locally advanced unresectable or metastatic disease. * Phase 2 metastatic urothelial cancer (mUC) Cohort: Histologically documented UC that is metastatic or locally advanced unresectable. * Progressed or recurred following receipt of platinum-containing regimen and anti-PD-1/PD-L1 therapy for metastatic or locally advanced unresectable disease Key Exclusion Criteria: * Positive serum pregnancy test, or females who may possibly be pregnant * Known Gilbert's disease * Have previously received antibody drug conjugate containing topoisomerase I inhibitors * Presence of bulky disease (defined as any single mass \> 7 cm in greatest dimension). * Known to be HIV positive, or hepatitis B virus (HBV) surface antigen positive or hepatitis C virus (HCV) antibody positive at screening * Known history of significant cardiac disease * Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness * History of interstitial lung disease * History of clinically significant gastrointestinal (GI) bleeding, have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation * Individuals with a history of anaphylactic reaction to irinotecan. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma hormone receptor-positive breast cancer neoplasm triple-negative breast carcinoma urothelial carcinoma

As listed by the trial registrant

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

Advanced solid tumor HR+/HER2- metastatic breast cancer Metastatic triple-negative breast cancer Metastatic urothelial cancer

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Aichi, 464-8681, Japan

  • Akita University Hospital

    Akita, 010-8543, Japan

  • Chiba Cancer

    Chūōku, 260-8717, Japan

  • Chiba Cancer Center

    Chiba, 260-8717, Japan

  • Hirosaki University Hospital

    Aomori, 036-8563, Japan

  • Hiroshima University Hospital

    Minamiku, 734-8551, Japan

  • Hyogo Cancer Center

    Hyōgo, 673-8558, Japan

  • Hyogo College of Medicine College Hospital

    Nishinomiya-shi, 663-8501, Japan

  • Juntendo University Hospital

    Bunkyō City, 113-8431, Japan

  • Kagawa University Hospital

    Kagawa, 761-0793, Japan

  • Kanagawa Cancer Center

    Asahi-ku, 241-8515, Japan

  • Keio University Hospital

    Tokyo, 1608582, Japan

  • Kindai University Hospital

    Osaka, 577-8502, Japan

  • Kindai University Hospital

    Osakasayama-shi, 589-8511, Japan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Nagoya University Hospital

    Chūōku, 540-0006, Japan

  • Nara Medical University Hospital

    Nara, 634-8522, Japan

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Cancer Center hospital

    Tokyo, 104-0045, Japan

  • National Center for Global Health and Medicine

    Shinjuku-ku, 162-8655, Japan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804, Japan

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280, Japan

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Osaka International Cancer Institute

    Chūōku, 541-8567, Japan

  • Osaka International Cancer Institute

    Osaka, 5418567, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-0051, Japan

  • Osaka University Hospital

    Osaka, 565-0871, Japan

  • Saitama Medical University

    Saitama, 350-1298, Japan

  • Shikoku Cancer Center

    Ehime, 791-0245, Japan

  • Showa University Hospital

    Tokyo, 142-8555, Japan

  • The Cancer Institute Hospital of JFCR

    Kōtō City, 135-8550, Japan

  • Tohoku University Hospital

    Aoba-ku, 980-8574, Japan

  • Tokai University School of Medicine

    Kanagawa, 259-1193, Japan

  • Tokyo Medical And Dental University, Medical Hospital

    Tokyo, 113-8519, Japan

  • Yamaguchi University Hospital

    Yamaguchi, 755-0046, Japan

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