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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Phase 1b Combo w/ Ribociclib and Alpelisib

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).
Breast, Phase I
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
BYL719 (Alpelisib), OP-1250, Ribociclib
Nunnery, Sara
International
Vanderbilt University
03-16-2023
Treatment
VICCBREP2267
NCT05508906

Eligibility

18 Years
BOTH
NO
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

To learn more about any of our clinical
trials, call 615-936-8422.