Study of Sacituzumab Govitecan in Japanese Patients with Advanced Solid Tumors or Triple-negative Breast Cancer (ASCENT-J02)
- Conditions
- advanced solid tumors Metastatic Triple-Negative Breast CancerHR+/HER2-Metastatic Breast Cancer
- Registration Number
- JPRN-jRCT2031210346
- Lead Sponsor
- Iwahori Yuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 143
1) Eastern Cooperative Oncology Group (ECOG) performance status =< 1
2) Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria
3) Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
4) Adequate hepatic function (bilirubin =< 1.5 upper limit of normal [ULN]), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 ULN
5) Creatinine clearance >= 30 mL/min
6) Male patients and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
7) 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.
8) Phase 2 metastatic triple-negative breast cancer (mTNBC) Cohort: Histologicallyor 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.
9) Phase 2 hormone receptor-positive/human epidermal growth factor receptor2-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.
10) 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.
1) Positive serum pregnancy test, or females who may possibly be pregnant
2) Known Gilbert's disease
3) Have previously received antibody drug conjugate containing topoisomerase I inhibitors
4) Presence of bulky disease (defined as any single mass > 7 cm in greatest dimention).
5) Known to be HIV positive, or hepatitis B virus (HBV) surface antigen positive or hepatitis C virus (HCV) antibody positive at screening.
6) Known history of significant cardiac disease
7) Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness
8) History of interstitial lung disease.
9) History of clinically significant gastrointestinal (GI) bleeding, have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation
10) Individuals with a history of anaphylactic reaction to irinotecan
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method