OncoMatch/Clinical Trials/NCT05035745
Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)
Is NCT05035745 recruiting? Yes, currently enrolling (May 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
Cancer type
Tumor Agnostic
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
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.
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