Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer
Sponsor: Daiichi Sankyo Co., Ltd. + Daiichi Sankyo, Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 28 days post last dose, up to approximately 9 months
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Time frame: From screening until disease progresses, up to approximately 9 months
Secondary Endpoints
Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd
Dose Finding Part: AUC of Anti-HER3-ac-DXd
Dose Expansion Part: AUC of Anti-HER3-ac-DXd
Eligibility Criteria
Key Inclusion Criteria: 1. Is 18 Years and older in the United States or 20 Years and older in Japan 2. Has a pathologically documented advanced/unresectable or metastatic breast cancer 3. Documented HER3-positive disease measured by immunohistochemistry (IHC) 4. Has disease that is refractory to or intolerable with standard treatment, or for which standard treatment no longer is available 5. Has an Eastern Cooperative Oncology Group Performance Status 0-1 6. Has Left Ventricular Ejection Fraction ≥ 50% 7. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Additional Inclusion Criteria for Dose Finding Part and Dose Expansion Part: 8. Has received 2-6 prior chemotherapy regimens for breast cancer, at least 2 of which were administered for treatment of advanced/unresectable or metastatic disease. At least 1 prior chemotherapeutic regimen must have included a taxane, administered in the neoadjuvant, adjuvant, or advanced setting. (With …
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