Study of Sacituzumab Govitecan-hziy (SG) in Japanese Participants With Advanced Solid Tumors or Triple-negative Breast Cancer

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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 (dose expansion): to evaluate the efficacy of SG in Japanese participants with triple-negative breast cancer (TNBC).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key 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 only: Expansion; Histologically- or cytologically-confirmed TNBC per American Society of Clinical Oncologists/College of American Pathologists 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 (mBC).

Key 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.