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Active, not recruiting Phase 1/2

Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors

NCT05101096 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1/2
Started
2021-10-20
Last updated
2026-07-10

Condition(s) studied

Advanced Solid TumorMetastatic Triple-Negative Breast CancerHR+/HER2- Metastatic Breast CancerMetastatic Urothelial Cancer

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziy →

Sacituzumab Govitecan-hziy: Administered intravenously (IV)

Study summary

The primary objectives of this study are as follows:

Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose (RP2D) of SG in Japanese participants with advance solid tumors.

Phase 2: Evaluate the safety and efficacy of SG in Japanese participants with metastatic triple-negative breast cancer (mTNBC), hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC), and metastatic urothelial cancer (mUC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 — First dose date to last dose date (Up to 15 weeks) plus 30 days
  • Phase 1: Percentage of Participants Experiencing Laboratory Abnormalities Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 — First dose date to last dose date (Up to 15 weeks) plus 30 days
  • Phase 1: Percentage of Participants Experiencing Dose-limiting toxicity (DLTs) per Dose level — First dose date up to 21 days
  • Phase 2:(Metastatic Triple-negative Breast Cancer (mTNBC);Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Metastatic Breast Cancer (HR+/HER2- mBC) Cohorts):Objective Response Rate (ORR) as Assessed by IRC — Up to 17 months
    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), confirmed at least 4 weeks later as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Independent Review Committee (IRC).
  • Phase 2 (Metastatic Urothelial Cancer (mUC) Cohort): ORR as Assessed by Investigator — Up to 17 months
    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) confirmed at least 4 weeks later as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Trial sites (36)

FacilityCityRegionStatus
Aichi Cancer Center Hospital Aichi Japan
Akita University Hospital Akita Japan
Tohoku University Hospital Aoba-ku Japan
Hirosaki University Hospital Aomori Japan
Kanagawa Cancer Center Asahi-ku Japan
Juntendo University Hospital Bunkyō City Japan
Chiba Cancer Center Chiba Japan
National Cancer Center Hospital East Chiba Japan
Chiba Cancer Chūōku Japan
Nagoya University Hospital Chūōku Japan
Osaka International Cancer Institute Chūōku Japan
Shikoku Cancer Center Ehime Japan
National Hospital Organization Shikoku Cancer Center Ehime Japan
Hyogo Cancer Center Hyōgo Japan
Kagawa University Hospital Kagawa Japan
Tokai University School of Medicine Kanagawa Japan
The Cancer Institute Hospital of JFCR Kōtō City Japan
Kumamoto University Hospital Kumamoto Japan
Kyoto University Hospital Kyoto Japan
Hiroshima University Hospital Minamiku Japan
Nara Medical University Hospital Nara Japan
Hyogo College of Medicine College Hospital Nishinomiya-shi Japan
Okayama University Hospital Okayama Japan
Osaka International Cancer Institute Osaka Japan
Osaka Metropolitan University Hospital Osaka Japan
Osaka University Hospital Osaka Japan
Kindai University Hospital Osaka Japan
Kindai University Hospital Osakasayama-shi Japan
Saitama Medical University Saitama Japan
National Hospital Organization Hokkaido Cancer Center Sapporo Japan
National Center for Global Health and Medicine Shinjuku-ku Japan
National Cancer Center hospital Tokyo Japan
Tokyo Medical And Dental University, Medical Hospital Tokyo Japan
Showa University Hospital Tokyo Japan
Keio University Hospital Tokyo Japan
Yamaguchi University Hospital Yamaguchi Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05101096 on ClinicalTrials.gov ↗ ← All trials in Japan