Advanced Refractory Solid Tumors Clinical Trial
Official title:
Phase I Dose Finding Study of Selinexor and Talazoparib in Patients With Advanced Refractory Solid Tumors, Followed by Phase II Expansion Cohort Study in Patients With Advanced/ Metastatic Triple Negative Breast Cancers. (START)
This is a single arm, open-label, phase I dose finding study, followed by a phase II expansion study. Phase I will be carried out in a modified 3+3 dose escalation design, with a projected enrolment of 33 patients with refractory solid tumors to determine the RP2D. In the phase II portion, a total of 30 patients with advanced/metastatic TNBC will be enrolled.
Hypothesis The investigators hypothesize that the combination of Talazoparib and Selinexor will have clinical efficacy in TNBC, independent of BRCA mutation status. Primary Objectives - To determine the safety profile of combination of Talazoparib and Selinexor in advanced/ metastatic solid tumors. - To determine the RP2D of Talazoparib and Selinexor combination therapy in patients with advanced/ metastatic solid tumors. Secondary Objectives • To determine the objective response rate to combination Talazoparib and Selinexor in advanced/ metastatic TNBCs. Exploratory Objectives - To assess the effect of the combination on pharmacokinetics of Talazoparib and Selinexor - To explore the impact of pharmacogenetics on toxicity and efficacy of combination Talazoparib and Selinexor. - To assess changes in circulating tumor cells and plasma biomarkers during treatment. - To assess pharmacodynamic changes and predictive biomarkers in tumor tissue during treatment. ;
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