Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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