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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
AeRang Kim
Study ID
NCT06735820
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APG-115 — DRUG
    Combination therapy of APG-115 and Selumetinib
  • Selumetinib — DRUG
    Combination therapy of APG-115 and Selumetinib

Study Details

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

Key Dates

Start date
Oct 1, 2025
Status verified
Jul 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: APG-115 and Selumetinib
    There is only one arm. It is combination therapy of APG-115 and Selumetinib.

Primary Outcome Measure

The number of treated patients with adverse events as determined by the common criteria for adverse version 5 (CTCAEv5). [ Time Frame: 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010-

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By research site
Children's National Hospital· Washington D.C., DC

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