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

NCT05035745 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Soo Chin Lee · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05035745 on ClinicalTrials.gov