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