Actively Recruiting
Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)
Led by National University Hospital, Singapore · Updated on 2025-07-25
63
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- No prior treatment with any PARP inhibitor including Talazoparib.
- No prior therapy with Selinexor.
- Age 18 years or older.
- Estimated life expectancy of at least 12 weeks.
- Recovery from acute toxicities of prior cancer treatments to grade 2 or lower.
- For phase I: advanced or metastatic solid tumors with progressive disease unlikely to benefit from standard therapy.
- For phase II: advanced or metastatic triple negative breast cancer with progression after at least one prior cancer therapy.
- Measurable disease by RECIST 1.1 criteria.
- ECOG performance status of 0 or 1.
- Adequate bone marrow, liver, and kidney function within 2 weeks before treatment.
- Ability to swallow tablets or pills.
- Ability to comply with study procedures.
- Female patients of childbearing potential must have negative pregnancy test and agree to use effective contraception during and for 7 months after treatment.
You will not qualify if you...
- Treatment with any investigational drug within 30 days prior to study.
- Concurrent use of other cancer therapies including chemotherapy, hormonal, or immunotherapy.
- Major surgery within 28 days before starting study treatment.
- Active infection compromising ability to tolerate therapy.
- Serious disorders that risk safety or study completion.
- Pregnancy or breastfeeding.
- Poorly controlled diabetes mellitus.
- Clinically detectable second primary malignancy (phase II only).
- Symptomatic brain metastases.
- History of significant neurological or mental disorders.
- Inability to comply with study procedures.
- Current or expected use of strong P-gp or BCRP inhibitors listed in the criteria.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
S
Soo Chin Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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