A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations (ACCURACY)

 Adenoid Cystic Carcinoma / Posted 3 months ago

AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane.

In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously

  • Inclusion Criteria :
    • 1. Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy.
    • 2. Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
    • 3. Patients must have Formalin-fixed, Paraffin-embedded tissue available .
    • 4. Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.
  • Exclusion Criteria :
    • 1. Diagnosed with a malignancy other than ACC in the past 2 years.
    • 2. Uncontrolled, Active Infection
    • 3. Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
    • 4. Symptomatic central nervous system (CNS) metastases.
    • 5. Unstable or severe uncontrolled medical condition
    • 6. Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
    • 7. Abnormal organ and marrow function
  • Study end date : 01/07/2021
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Gary Gordon, Dr.
Contact details

The Christie NHS Foundation Trust, Manchester, United Kingdom, M20 4BXManchester,England,M20 4BX

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