Breast Cancer Clinical Trial
Phase 1b Combo w/ Ribociclib and Alpelisib
Summary
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).
Full Description
Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics (PK) of a range of doses of OP-1250 administered orally (PO) every day (QD) to subjects in combination with either 600 mg of ribociclib administered PO QD (Treatment Group 1) or with 300 mg of alpelisib administered PO QD (Treatment Group 2) to determine the recommended phase 2 dose (RP2D). The dose escalation phase will evaluate 3 to 6 subjects per cohort who are sequentially enrolled and monitored for DLTs during the first cycle of study treatment. Each cohort will be reviewed for safety, PK, and dose-limiting toxicity DLTs. The DLT observation may be extended to 2 cycles.
Part 2 (Dose Expansion): This part of the study will further evaluate the safety and PK of OP-1250 at the RP2D in combination with either ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) and provide an exploratory estimate of anti-tumor activity of the combinations.
Eligibility Criteria
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 2 prior hormonal regimens for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4/6 inhibitors are allowed.
Has received no more than 1 prior chemotherapy 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
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There is 1 Location for this study
Orlando Florida, 32804, United States
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