Spots Global Cancer Trial Database for Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)

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Trial Identification

Brief Title: Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)

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)

Study ID: NCT05035745

Conditions

Advanced Refractory Solid Tumors

Advanced Triple Negative Breast Cancers

Metastatic Triple Negative Breast Cancers

Interventions

Talazoparib

Selinexor

Study Description

Brief Summary: 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.

Detailed Description: 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.