Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
NCT ID: NCT05101096
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
135 participants
INTERVENTIONAL
2021-10-20
2026-05-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Sacituzumab Govitecan-hziy 6 mg, Advanced Solid Tumors
(Phase 1 Cohort A: dose escalation) Japanese participants with advanced solid tumors will receive sacituzumab govitecan-hziy (SG) 6 mg/kg by intravenous (IV) injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Sacituzumab Govitecan-hziy 8 mg, Advanced Solid Tumors
(Phase 1 Cohort A: dose escalation) Japanese participants with advanced solid tumors will receive SG 8 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Sacituzumab Govitecan-hziy 10 mg, Advanced Solid Tumors
(Phase 1 Cohort A: dose escalation) Japanese participants with advanced solid tumors will receive SG 10 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Sacituzumab Govitecan-hziy 6 mg, UGT1A1 Polymorphism
(Phase 1 Cohort B: dose escalation) Japanese participants with UGT1A1 polymorphism will receive SG 6 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Sacituzumab Govitecan-hziy 10 mg, UGT1A1 Polymorphism
(Phase 1 Cohort B: dose escalation) Japanese participants with UGT1A1 polymorphism will receive SG 10 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Sacituzumab Govitecan-hziy, Metastatic Triple-negative Breast Cancer (mTNBC)
(Phase 2: dose expansion) Japanese participants with mTNBC will receive SG at the recommended Phase 2 dose (RP2D) on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Sacituzumab Govitecan-hziy, HR+/HER2- Metastatic Breast Cancer (HR+/HER2- mBC)
(Phase 2) Japanese participants with HR+/HER2- mBC will receive SG at the recommended Phase 2 dose (RP2D) on Day 1 and Day 8 of a 21 day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Sacituzumab Govitecan-hziy, Metastatic Urothelial Carcinoma (mUC)
(Phase 2) Japanese participants with mUC will receive SG at the recommended Phase 2 dose (RP2D) on Day 1 and Day 8 of a 21 day cycle until disease progression or unacceptable toxicity.
Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Interventions
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Sacituzumab Govitecan-hziy
Administered intravenously (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Countries
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References
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Naito Y, Nakamura S, Kawaguchi-Sakita N, Ishida T, Nakayama T, Yamamoto Y, Masuda N, Matsumoto K, Kogawa T, Sudo K, Shimomura A, Lai C, Zhang D, Iwahori Y, Gary D, Huynh D, Iwata H. Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors. Int J Clin Oncol. 2024 Nov;29(11):1684-1695. doi: 10.1007/s10147-024-02589-x. Epub 2024 Sep 20.
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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jRCT2031210346
Identifier Type: REGISTRY
Identifier Source: secondary_id
GS-US-569-6172
Identifier Type: -
Identifier Source: org_study_id
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