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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNational University Hospital, Singapore

About this trial

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.

Eligibility criteria

Qualifiers

All patients must sign an informed consent in accordance with local institutional guidelines.

All patient must not have received prior PARPi including talazoparib

All patients must not have prior therapy with selinexor.

Age ≥ 18

Disqualifiers

Measurable disease by RECIST 1.1 criteria.

Eastern cooperative Oncology Group (ECOG) Performance Status of 0-1

Adequate bone marrow function and organ function within 2 weeks of study treatment

Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L

Trial design

Treatments tested in this trial

  • Talazoparib
  • Selinexor

Treatment groups

63 Participants
are divided into 1 treatment group