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A Study of Selinexor for Wilms Tumors and Other Solid Tumors

This study is testing a drug called selinexor to see if it can effectively treat certain solid tumors that have come back or are difficult to treat. These include Wilms tumor, rhabdoid tumor, MPNST (Malignant Peripheral Nerve Sheath Tumors), BCOR-driven sarcoma, or other solid tumors with high levels of XPO1 protein or genetic changes that increase its activity. The study will give selinexor as a liquid once a week. We want to see how many people respond to the treatment within 6 months. This study is open to people aged 12 months and older. The current recruitment status is unclear, and the study plans to enroll 45 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase 2 study, and all participants will receive selinexor.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Overall Response Rate, will be measured at 6 months after starting treatment.

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NCT05985161

A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors

Recruiting
PHASE2Ages 12+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~45 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Selinexor

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate
Measured over 6 months following the start of the treatment

Conditions

Wilms Tumor
Rhabdoid Tumor
Malignant Peripheral Nerve Sheath Tumors
MPNST
Nephroblastoma
XPO1 Gene Mutation
Solid Tumor

Explore related trials

Malignant Peripheral Nerve Sheath TumorRhabdoid TumorSolid NeoplasmWilms Tumor

Where it's being run

16 sites across 10 states
New York4
New Jersey3
California2
District of Columbia1
Georgia1
Illinois1
Massachusetts1
Missouri1

Study leadership

  • Michael Ortiz, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Michael Ortiz, MD
[email protected]
1-833-MSK-KIDS
Email the study team

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Eligibility criteria

Inclusion

Age:
Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Performance: Karnofsky ≥ 60% for patients \> 16 years of age and Lansky ≥ 60 for patients ≤ 16 years of age.
Diagnosis: Patients must enroll into one of the following cohorts:
Cohort E: Patients must have a solid tumor with an activating genomic alteration (e.g. fusion or internal tandem duplication) involving BCOR. Specific examples of qualifying alterations including BCOR-ITD, BCOR-CCNB3, BCOR-MAML3 and ZC3H7B-BCOR; Other potentially qualifying BCOR alterations require approval of study principal investigator; note that loss of function alterations of BCOR would not qualify.
Disease Status: Patients on the phase II portion of the study must have measurable disease whereas patients on the PK cohorts can have either evaluable or measurable disease as measured by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (Version 1.1).
Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and meet minimum washout durations (shown below) from prior therapy.
Hepatic Function: Adequate function (within 14 days prior to C1D1), defined as:
Renal Function: Adequate function (within 14 days prior to C1D1) defined as a GFR
Hematologic Function: Adequate function (within 14 days prior to C1D1), defined as:

Exclusion

Prior Therapy: Has received selinexor or another XPO1 inhibitor previously.
Infection: Patients who have an uncontrolled infection are not eligible. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable
Transplants: Patients who have received allogeneic bone marrow transplant are potentially eligible unless they are being actively treated for GvHD. Patients who have had a prior solid organ transplantation are not eligible.
Compliance: Patients who as a result of serious medical, psychiatric, and/or social situation(s), in the opinion of the investigator, may not be able to comply with supportive care, safety monitoring, or any other key requirements of the study protocols are not eligible.
Pregnancy and Breast-feeding: Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal.
Contraception: Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control.

What this trial measures

  • Overall Response Rate6 months following the start of the treatment

    To define the antitumor activity of Selinexor in relapsed and refractory Wilms tumor by measuring the Overall Response Rate, defined as Complete Response + Partical Response