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Early Phase Study Evaluating MEK and MDM2 Inhibition in Patients With NF1 and MPNST

NCT06735820 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-07-03

No results posted yet for this study

Summary

This is a phase 0/1/2, multi-site study to evaluate the MEK inhibitor Selumetinib with the MDM2 Inhibitor APG-115 in patients with Neurofibromatosis Type 1 and pre-malignant and malignant peripheral nerve sheath tumors

Conditions

  • Malignant Peripheral Nerve Sheath Tumor (MPNST)
  • Neurofibromatosis 1 (NF1)
  • Atypical Neurofibroma

Interventions

DRUG

APG-115

Combination therapy of APG-115 and Selumetinib

DRUG

Selumetinib

Combination therapy of APG-115 and Selumetinib

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • AeRang Kim

    lead OTHER

Principal Investigators

  • AeRang Kim, MD, PhD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-10-01
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735820 on ClinicalTrials.gov