A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
About this trial
This is an interventional treatment trial for Hormone Receptor Positive Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must not have received prior oral endocrine therapy > 2 weeks prior to first dose
- Must not have received prior fulvestrant, chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
- Adequate hepatic function
- Adequate renal function
- Normal coagulation panel
- Willingness to use effective contraception
Exclusion Criteria:
- Gastrointestinal disease
- Significant renal disease
- Significant cardiovascular disease
- Significant ECG abnormalities
- Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
- Pregnancy or breastfeeding
Sites / Locations
- UCLA Hematology/Oncology
- University of Colorado
- University of Miami, Sylvester Comprehensive Cancer Center
- Advent Health
- Florida Cancer Center
- Winship Cancer Institute of Emory University
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
- Dana Farber Cancer Institute
- Saint Luke's Hospital of Kansas City
- Montefiore Medical Center
- Cleveland Clinic Taussig Cancer Center
- Ohio State University Comprehensive Cancer Center
- Providence Portland Medical Center
- OHSU Knight Cancer Institute
- Sarah Cannon Research Institute
- Macquarie University
- Westmead
- ICON Cancer Centre
- Cancer Research South Australia
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
OP-1250 Phase I Part A (Dose Escalation) and Part B (Dose Expansion)
OP-1250 Phase II
Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose.
This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts. Cohort A will enroll subjects with measurable disease without evidence of CNS metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases.