NCT05035745

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

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Refractory Solid Tumors
• Advanced Triple Negative Breast Cancers
• Metastatic Triple Negative Breast Cancers

Interventions

Type	Name	Description
DRUG	Talazoparib	Patients will be treated with Talazoparib daily on a 4 weekly cycle (28 days)
DRUG	Selinexor	Patients will be treated with Selinexor once per week (3 out of 4 weeks), on a 4 weekly cycle (28 days)

Timeline

• Start date: 2021-03-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2021-09-05
• Last updated: 2025-07-25

Locations

1 site across 1 country: Singapore