Early Phase Study on MEK and MDM2 Inhibitors for Patients with NF1 and Nerve Tumors

Sponsor: AeRang Kim

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06735820

Provider View

This study is testing a combination of two drugs, Selumetinib and APG-115, to see if they are safe and effective for treating patients with Neurofibromatosis Type 1 (NF1) and certain types of nerve tumors.

Patient Parameters

Program Overview

The study aims to find out if the drugs Selumetinib and APG-115 are safe and can help treat patients with Neurofibromatosis Type 1 (NF1) who have specific nerve tumors that are either pre-cancerous or cancerous. The study is divided into three parts: Part A focuses on safety and dosage, Part B looks at the benefits of the treatment, and Part C examines how the drugs affect tumor growth in patients who are planning to have surgery.

Description

This clinical trial is exploring the use of two drugs, Selumetinib and APG-115, in patients with Neurofibromatosis Type 1 (NF1) who have certain types of nerve tumors. The study is divided into three parts:

  • Part A: The main goal is to determine the safety and appropriate doses of the drugs in patients with NF1 and tumors that cannot be removed by surgery.
  • Part B: This part aims to see if the drugs provide any clinical benefits to patients with NF1 and tumors that are difficult to treat or have returned after previous treatments.
  • Part C: Researchers will evaluate how the drugs affect tumor growth in patients with pre-cancerous nerve tumors who are planning to have surgery.

Participants will undergo various tests and procedures to monitor their health and the effects of the treatment. The study will help determine if this combination of drugs can be a viable treatment option for patients with NF1 and nerve tumors.

Eligibility Criteria

Inclusion Criteria

  • Age: Part A and C: 18 years or older; Part B: 12 years or older with a body surface area of at least 0.55m².
  • Diagnosis: Patients with NF1 and specific types of nerve tumors that cannot be removed by surgery.
  • Measurable Disease: Must have tumors that can be measured by scans.
  • Previous Treatments: Must have tried other treatments that did not work or were not suitable.
  • Health Requirements: Must have recovered from previous treatments and meet specific health criteria, including blood counts and organ function.
  • Performance Status: Must be able to perform daily activities with some limitations.
  • Other Requirements: Must agree to use birth control if of childbearing potential and have no other active cancer treatments.

Exclusion Criteria

  • Other Cancers: History of another cancer unless treated and inactive for at least 2 years.
  • Current Treatments: Cannot be receiving other cancer treatments.
  • Medical Conditions: No severe or uncontrolled medical conditions that could interfere with the study.
  • Surgery: No recent major surgery within 4 weeks before starting the study.
  • Medications: Cannot be taking certain medications or supplements that could interfere with the study drugs.
  • Pregnancy: Cannot be pregnant or breastfeeding during the study.

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