PHASE 1/2A DOSE ESCALATION FINDING AND EXPANSION STUDY EVALUATING SAFETY TOLERABILITY PHARMACOKINETICS PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY
Brief description of study
The purpose of the study is to investigate the safety, tolerability of study drug PF-07104091, a CDK2 inhibitor, when administered as a single agent and then in combination with a CDK4/6 inhibitor (palbociclib) and endocrine therapy (fulvestrant or letrozole). CDK inhibitors treat cancer by blocking cancer cells at a critical time point in their growth cycle. Specifically the study aims to determine the maximum tolerated study drug dose PF-07104091 and it's activity as a single agent and as part of combination therapy. Predictive biomarkers of response will also be assessed.
The study drug PF-07104091 is investigational, which means that the study drug has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test the study drug in the current trial.
This study is enrolling patients with Breast cancer, Small Cell Lung Cancer and specific gynecologic malignancies including ovarian cancer.
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