Phase 1b Study in Combination With a CDK4/6 Inhibitor or With a PI3K Inhibitor

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olema Pharmaceuticals, Inc.
• Collaborator: Novartis

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