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

NCT05101096 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: GS-US-569-6172jRCT2031210346
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 36

Brief 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).

Conditions

Advanced Solid Tumor; Metastatic Triple-Negative Breast Cancer; HR+/HER2- Metastatic Breast Cancer; Metastatic Urothelial Cancer

Outcome Measures

Primary Outcomes (5)

• 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

  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).

  Up to 17 months

• Phase 2 (Metastatic Urothelial Cancer (mUC) Cohort): ORR as Assessed by Investigator

  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)

  Up to 17 months

Secondary Outcomes (14)

• Phase 1: Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy (SG) and Free SN-38

  Up to 33 months

• Phase 1: PK Parameter: Tmax of SG and Free SN-38

  Up to 33 months

• Phase 1: PK Parameter: AUC0-168h of SG and Free SN-38

  Up to 33 months

• Phase 1 : Percentage of Participants Who Develop Anti-Drug Antibodies (ADAs) Against SG

  Up to 33 months

• Phase 2 (All Cohorts): Percentage of Participants Experiencing TEAEs Defined by NCI CTCAE Version 4.03

  First dose date to last dose date (Up to 33 months) plus 30 days

Study Arms (8)

Sacituzumab Govitecan-hziy 6 mg, Advanced Solid Tumors

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy 8 mg, Advanced Solid Tumors

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy 10 mg, Advanced Solid Tumors

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy 6 mg, UGT1A1 Polymorphism

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy 10 mg, UGT1A1 Polymorphism

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy, Metastatic Triple-negative Breast Cancer (mTNBC)

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy, HR+/HER2- Metastatic Breast Cancer (HR+/HER2- mBC)

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy, Metastatic Urothelial Carcinoma (mUC)

EXPERIMENTAL

(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.

Drug: Sacituzumab Govitecan-hziy

Interventions

Sacituzumab Govitecan-hziy DRUG

Administered intravenously (IV)

Also known as: IMMU-132, Trodelvy™, GS-0132

Sacituzumab Govitecan-hziy 10 mg, Advanced Solid Tumors; Sacituzumab Govitecan-hziy 10 mg, UGT1A1 Polymorphism; Sacituzumab Govitecan-hziy 6 mg, Advanced Solid Tumors; Sacituzumab Govitecan-hziy 6 mg, UGT1A1 Polymorphism; Sacituzumab Govitecan-hziy 8 mg, Advanced Solid Tumors; Sacituzumab Govitecan-hziy, HR+/HER2- Metastatic Breast Cancer (HR+/HER2- mBC); Sacituzumab Govitecan-hziy, Metastatic Triple-negative Breast Cancer (mTNBC); Sacituzumab Govitecan-hziy, Metastatic Urothelial Carcinoma (mUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (36)

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

Tohoku University Hospital

Aoba-ku, 980-8574, Japan

Location

Hirosaki University Hospital

Aomori, 036-8563, Japan

Location

Kanagawa Cancer Center

Asahi-ku, 241-8515, Japan

Location

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

Chiba Cancer

Chūōku, 260-8717, Japan

Location

Nagoya University Hospital

Chūōku, 540-0006, Japan

Location

Osaka International Cancer Institute

Chūōku, 541-8567, Japan

Location

Shikoku Cancer Center

Ehime, 791-0245, Japan

Location

National Hospital Organization Shikoku Cancer Center

Ehime, 791-0280, Japan

Location

Hyogo Cancer Center

Hyōgo, 673-8558, Japan

Location

Kagawa University Hospital

Kagawa, 761-0793, Japan

Location

Tokai University School of Medicine

Kanagawa, 259-1193, Japan

Location

The Cancer Institute Hospital of JFCR

Kōtō City, 135-8550, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Hiroshima University Hospital

Minamiku, 734-8551, Japan

Location

Nara Medical University Hospital

Nara, 634-8522, Japan

Location

Hyogo College of Medicine College Hospital

Nishinomiya-shi, 663-8501, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute

Osaka, 5418567, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-0051, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Kindai University Hospital

Osaka, 577-8502, Japan

Location

Kindai University Hospital

Osakasayama-shi, 589-8511, Japan

Location

Saitama Medical University

Saitama, 350-1298, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, 003-0804, Japan

Location

National Center for Global Health and Medicine

Shinjuku-ku, 162-8655, Japan

Location

National Cancer Center hospital

Tokyo, 104-0045, Japan

Location

Tokyo Medical And Dental University, Medical Hospital

Tokyo, 113-8519, Japan

Location

Showa University Hospital

Tokyo, 142-8555, Japan

Location

Keio University Hospital

Tokyo, 1608582, Japan

Location

Yamaguchi University Hospital

Yamaguchi, 755-0046, Japan

Location

Related Publications (1)

• 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.

  PMID: 39302614 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: October 20, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (36)