Asciminib with or without Sildenafil for Brain Tumors

This study is looking at how well the drug asciminib, with or without sildenafil, gets into brain tumors. Asciminib is already approved for a type of leukemia and is thought to help with brain tumors by targeting certain proteins (ABL1 and ABL2) that can make tumors spread. Sildenafil might help asciminib get into the tumor better. Researchers will measure the amount of asciminib in the tumor compared to the blood during surgery or biopsy. This study is for people aged 18-39 with a brain tumor that has come back or is growing, and who are able to have surgery or a biopsy. The study aims to enroll 12 participants.

Study design: This is an interventional study with an unclear status, planning to enroll 12 participants. It is not specified if it's randomized or single-arm.
What's involved: Participants would undergo surgical resection or biopsy, which is standard care. The amount of asciminib in the tumor and blood will be measured at the time of this procedure.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoints are measured at the time of surgical resection or biopsy (day 1). It is not specified if there is follow-up after this point.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Asciminib With or Without Sildenafil for Brain Tumors

Not Yet Recruiting

EARLY_PHASE1Ages 18–39InterventionalTreatment

Washington University School of Medicine

~12 participants

Updated 2026-07-01 on ClinicalTrials.gov

What's tested:AsciminibSildenafilSurgical resection or biopsy

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Tumor:plasma ratio of asciminib

Measured over At time of surgical resection or biopsy (day 1)

+1 more outcome measured

Conditions

Brain Tumor

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Eric Thompson, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Eric Thompson, M.D.

[email protected]

314-454-4707

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ages 18-39 years old, inclusive.

Radiographic evidence of a recurrent/progressive brain tumor.

Tumor must be predominantly in an intraparenchymal location.

Deemed operable (able to be resected or have an open or stereotactic needle biopsy) by treating neurosurgeon.

ECOG Performance Status of ≥ 2. Patients who are unable to walk because of paralysis but who are up in a wheelchair will be considered ambulatory for the purposes of the performance score.

Bone Marrow:

ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported).

Platelets ≥ 100,000/µl (may be supported by transfusion).

Hemoglobin \> 8 g/dL (may be supported by transfusion).

Renal:

Serum creatinine ≤ upper limit of institutional normal.

Hepatic:

Bilirubin ≤ 1.5 times upper limit of normal for age.

ALT (SGPT) ≤ 3 times institutional upper limit of normal for age.

AST (SGOT) ≤ 3 times institutional upper limit of normal for age.

Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. All patients and/or their parents or legal guardians must sign an IRB approved written informed consent document.

Exclusion

Tumors suspected to be pituitary tumors or tumors of the meninges.

Tumors that are suspected of a non-CNS primary location or history of non-CNS malignancy).

Unable to take tablets orally

Pregnant and/or breastfeeding. Subjects of childbearing potential must have a negative serum or urine pregnancy test within 10 days prior to Day 1.

Active infection requiring treatment or an unexplained febrile (\> 101.5o F) illness.

Known immunosuppressive disease or human immunodeficiency virus infection.

Any active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.

Any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).

Inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.

What this trial measures

Tumor:plasma ratio of asciminibAt time of surgical resection or biopsy (day 1)
Tumor:plasma ratio of asciminib with sildenafilAt time of surgical resection or biopsy (day 1)

Trialytics