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

Overview

About this study

The primary purpose of this study is to assess the clinical activity of AL101 using radiographic assessments and Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Adenoid Cystic Carcinoma (ACC) patients with activating Notch mutations.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • 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. 
  • Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed. 
  • Patients must have Formalin-fixed, Paraffin-embedded tissue available. 
  • Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.

Exclusion Criteria: 

  • Diagnosed with a malignancy in the past 2 years. 
  • Infection.
  • Gastrointestinal (GI) disease with increased risk of diarrhea [e.g., inflammatory bowel disease (IBD)].
  • Symptomatic central nervous system (CNS) metastases. 
  • Unstable or severe uncontrolled medical condition.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Abnormal organ and marrow function

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Katharine Price, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20477732

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