OncoMatch/Clinical Trials/NCT05985161
A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors
Is NCT05985161 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Selinexor for wilms tumor.
Treatment: Selinexor — The purpose of this study is to find out whether selinexor is an effective treatment for people who have a relapsed/refractory Wilms tumor, rhabdoid tumor, MPNST, BCOR-driven sarcoma, or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes that increase the activity of XP01.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Tumor Agnostic
Biomarker criteria
Required: XPO1 e571k
Tumor XPO1 Activation: Defined as the detection of a gain of function mutation in XPO1, specifically E571K.
Required: XPO1 overexpression (elevated transcriptomic or proteomic expression)
detection of elevated transcriptomic or proteomic expression of XPO1 in the tumor via RNAseq or IHC
Required: XPO1 aberrant activation (aberrantly activated)
Darwin OncoTarget demonstrating XPO1 as aberrantly activated
Required: XPO1 context-specific tumor checkpoint inversion with selinexor (context-specific tumor checkpoint inversion)
Darwin OncoTreat demonstrating context-specific tumor checkpoint inversion with Selinexor
Required: BCOR internal tandem duplication
BCOR-ITD
Required: BCOR bcor-ccnb3 fusion
BCOR-CCNB3
Required: BCOR bcor-maml3 fusion
BCOR-MAML3
Required: BCOR zc3h7b-bcor fusion
ZC3H7B-BCOR
Demographics
Prior therapy
Must have received: systemic therapy
Patients must have failed to respond to at least 1 line of systemic therapy prior to enrollment.
Cannot have received: XPO1 inhibitor (selinexor)
Has received selinexor or another XPO1 inhibitor previously.
Lab requirements
Blood counts
ANC ≥ 1000/mm3; Platelet count ≥ 100,000/mm3; no platelet transfusions or hematopoietic growth factor support for at least 7 days prior to demonstrating adequate function
Kidney function
GFR ≥ 50 ml/min/1.73 m2 by nuclear radioisotope, 24 hr urine creatinine clearance, serum cystatin c, or Schwartz formula
Liver function
Total bilirubin < 1.5 × ULN (except Gilbert's syndrome <3 × ULN); ALT < 3 × ULN; serum albumin ≥ 2 g/dL
Hepatic: Total bilirubin < 1.5 × ULN (except Gilbert's syndrome <3 × ULN); ALT < 3 × ULN; serum albumin ≥ 2 g/dL. Renal: GFR ≥ 50 ml/min/1.73 m2 by nuclear radioisotope, 24 hr urine creatinine clearance, serum cystatin c, or Schwartz formula. Hematologic: ANC ≥ 1000/mm3; Platelet count ≥ 100,000/mm3; no platelet transfusions or hematopoietic growth factor support for at least 7 days prior to demonstrating adequate function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Los Angeles (Data Collection Only) · Los Angeles, California
- Stanford Medicine Children's Health (Data Collection Only) · Palo Alto, California
- Children's National Hospital (Data Collection Only) · Washington D.C., District of Columbia
- Children's Healthcare of Atlanta (Data Collection and Specimen Analysis) · Atlanta, Georgia
- Ann & Robert H. Lurie Children'S Hospital of Chicag · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05985161 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior XPO1 inhibitor disqualifies patients from enrollment.
Does this trial require XPO1?
Yes, XPO1 e571k is a required biomarker for enrollment.
Does this trial require XPO1?
Yes, XPO1 overexpression is a required biomarker for enrollment.
Does this trial require XPO1?
Yes, XPO1 aberrant activation is a required biomarker for enrollment.
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