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

Sponsor
National University Hospital, Singapore
Study ID
NCT05035745
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Jul 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with refractory solid tumors
    Phase I will be carried out in a modified 3+3 dose escalation design, with a projected enrolment of patients with refractory solid tumors to determine the RP2D.

Primary Outcome Measure

safety profile of combination of Talazoparib and Selinexor in advanced/ metastatic solid tumors using NCI CTCAE toxicity grading version 5.0. [ Time Frame: 5 years ]

Central Contacts

Related Studies