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STATUS Recruiting

Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors (ASCENT-J02)

LAST UPDATED

April 23, 2024

Clinicaltrials.gov ID

NCT05101096

OVERVIEW

A Phase 1/2 Open-Label Study of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors (ASCENT-J02) (ASCENT-J02)

PROTOCOL 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).

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

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

Gender

N/A

Date

October 2021 - May 2026

Study Type

Interventional

Study Phase

Phase 1, Phase 2

Product

Sacituzumab Govitecan-hziy

Eligibility Information

Inclusion

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 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
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Exclusion

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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Locations

Locations (35)
Recruiting

Aichi Cancer Center Hospital

Aichi, Japan, 464-8681

Recruiting

Akita University Hospital

Akita, Japan, 010-8543

Recruiting

Tohoku University Hospital

Aoba-ku, Japan, 980-8574

Recruiting

Hirosaki University Hospital

Aomori, Japan, 036-8563

Recruiting

Kanagawa Cancer Center

Asahi-ku, Japan, 241-8515

Recruiting

Juntendo University Hospital

Bunkyo-ku, Japan, 113-8431

Recruiting

Chiba Cancer Center

Chiba, Japan, 260-8717

Recruiting

National Cancer Center Hospital East

Chiba, Japan, 277-8577

Recruiting

Chiba Cancer

Chuo-ku, Japan, 260-8717

Recruiting

Nagoya University Hospital

Chuo-ku, Japan, 540-0006

Recruiting

Osaka International Cancer Institute

Chuo-ku, Japan, 541-8567

Recruiting

Shikoku Cancer Center

Ehime, Japan, 791-0245

Recruiting

National Hospital Organization Shikoku Cancer Center

Ehime, Japan, 791-0280

Recruiting

Hyogo Cancer Center

Hyogo, Japan, 673-8558

Recruiting

Kagawa University Hospital

Kagawa, Japan, 761-0793

Recruiting

Tokai University School of Medicine

Kanagawa, Japan, 259-1193

Recruiting

The Cancer Institute Hospital of JFCR

Koto, Japan, 135-8550

Recruiting

Kumamoto University Hospital

Kumamoto- shi, Japan, 860-8556

Recruiting

Hiroshima University Hospital

Minami-ku, Japan, 734-8551

Recruiting

Nara Medical University Hospital

Nara, Japan, 634-8522

Recruiting

Hyogo College of Medicine College Hospital

Nishinomiya-shi, Japan, 663-8501

Recruiting

Okayama University Hospital

Okayama, Japan, 700-8558

Recruiting

Kindai University Hospital

Osakasayama-shi, Japan, 589-8511

Recruiting

Osaka Metropolitan University Hospital

Osaka, Japan, 545-0051

Recruiting

Osaka University Hospital

Osaka, Japan, 565-0871

Recruiting

Kindai University Hospital

Osaka, Japan, 577-8502

Recruiting

Saitama Medical University

Saitama, Japan, 350-1298

Recruiting

Kyoto University Hospital

Sakyo-ku, Japan, 606-8507

Recruiting

National Hospital Organization Hokkaido Cancer Center

Sapporo, Japan, 003-0804

Recruiting

National Center for Global Health and Medicine

Shinjuku-ku, Japan, 162-8655

Recruiting

National Cancer Center hospital

Tokyo, Japan, 104-0045

Recruiting

Tokyo Medical And Dental University, Medical Hospital

Tokyo, Japan, 113-8519

Recruiting

Showa University Hospital

Tokyo, Japan, 142-8555

Recruiting

Keio University Hospital

Tokyo, Japan, 1608582

Recruiting

Yamaguchi University Hospital

Yamaguchi, Japan, 755-0046