OncoMatch/Clinical Trials/NCT05035745
Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)
Is NCT05035745 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Talazoparib and Selinexor for advanced refractory solid tumors.
Treatment: Talazoparib · Selinexor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Tumor Agnostic
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anti-cancer therapy
Patients must have evidence of progressive disease on study entry after at least one line of anti-cancer therapy
Cannot have received: PARP inhibitor (talazoparib)
must not have received prior PARPi including talazoparib
Cannot have received: XPO1 inhibitor (selinexor)
must not have prior therapy with selinexor
Cannot have received: investigational drug
Treatment within the last 30 days with any investigational drug
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelets ≥ 125 x 10^9/L (dose escalation), ≥ 100 x 10^9/L (dose expansion); Hemoglobin ≥ 9 x 10^9/L
Kidney function
Calculated creatinine clearance of ≥ 60 mL/min (Cockroft and Gault formula)
Liver function
Bilirubin ≤ 1.5 times ULN; ALT or AST ≤ 2.5 times ULN (or ≤ 5 times ULN with liver metastases)
Adequate bone marrow function and organ function within 2 weeks of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05035745 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PARP inhibitor, XPO1 inhibitor, investigational drug disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify