A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination with the CDK4/6 Inhibitor Ribociclib or with the PI3K Inhibitor Alpelisib in Adult Subjects with Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
Trial Description
This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups
are as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis
Pharmaceuticals Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis
Pharmaceuticals Corporation).
Eligibility Requirements
Inclusion Criteria:
- Female or male aged >18 years.
- Willing and able to participate and comply with all study requirements
- Histologically- or cytologically-confirmed advanced or MBC
- HR+/HER2- disease, as determined in the most recently obtained archival tumor tissue
sample from a metastatic site, using locally accepted criteria by the local
pathology report
- Evaluable disease (measurable and non-measurable): Measurable disease, ie, at least
1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may
only be counted as a target lesion if there is clear sign of progression since the
irradiation).-Subject must have received at least 6 months of a prior continuous
endocrine therapy for locally advanced or metastatic breast cancer
- Life expectancy ≥6 months, as judged by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Has received no more than 1 prior hormonal regimen (Treatment Group 1). Has received
no more than 2 prior hormonal regimens (Treatment Group 2) for advanced or
metastatic disease. Prior hormonal regimens in combination with CDK4/6 inhibitors
are allowed.
- Has received no more than 1 prior chemotherapy (which includes antibody drug
conjugates) for locally advanced or metastatic breast cancer.
Exclusion Criteria:
- Prior or concurrent malignancy whose natural history or treatment may interfere with
the safety or efficacy assessment of the investigational regimen
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization
abnormality
- History of cerebral vascular disease within 6 months prior to the first
administration of study drug dose
- History of a pulmonary embolism, or deep venous thrombosis within the last 6 months,
or subject has an increased risk of thrombosis as determined by the investigator
- History of pneumonitis or interstitial lung disease
- Leptomeningeal disease or spinal cord compression
- Medical history or ongoing gastrointestinal disorders that could affect absorption
of oral therapeutics
- Known human immunodeficiency virus infection
- Known clinically significant history of liver disease consistent with Child-Pugh
Class B or C, including active viral or other hepatitis (eg, hepatitis B or
hepatitis C virus), current alcohol abuse, or cirrhosis