Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05035745
Study type Interventional
Source National University Hospital, Singapore
Contact Soo Chin Lee
Phone 6779 5555
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date March 1, 2021
Completion date November 2025

See also
  Status Clinical Trial Phase
Suspended NCT01762410 - Clinical Study of Oral PI3K/mTOR Inhibitor in Patients With Advanced Refractory Solid Tumors Phase 1
Terminated NCT03195764 - Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors Phase 1
Completed NCT03349073 - An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors Phase 1
Recruiting NCT04892498 - Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0) Phase 2
Recruiting NCT04685473 - Safety and Tolerability Study for T-1101 (Tosylate) Capsules to Treat Advanced Refractory Solid Tumors Phase 1
Recruiting NCT04324372 - Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors Phase 1
Recruiting NCT02300467 - NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors Phase 1
Suspended NCT01779336 - Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors Phase 1
Recruiting NCT04200404 - A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT03863145 - Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors Early Phase 1