Study of AU-007, a Monoclonal Antibody for Patients with Advanced or Metastatic Cancer

Sponsor: Aulos Bioscience, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05267626

Provider View

This clinical trial is testing a new treatment called AU-007, which is a monoclonal antibody designed to target specific cancer cells. The study aims to evaluate the safety and effectiveness of AU-007 in patients with advanced cancers that cannot be surgically removed.

Patient Parameters

Program Overview

This study is the first of its kind to test AU-007, a new treatment for patients with advanced solid tumors. The trial will assess how safe and tolerable AU-007 is, and whether it can help treat cancers that have spread or cannot be removed by surgery. AU-007 will be tested alone or in combination with another drug called aldesleukin, given every two weeks. The study will take place in multiple centers and will include patients who have not responded to standard treatments or are not eligible for them.

Description

This clinical trial is exploring a new treatment called AU-007 for patients with advanced cancers that cannot be surgically removed. The study is divided into several parts:

  • Part 1: This phase will test different doses of AU-007, both alone and in combination with a drug called aldesleukin, to find the safest and most effective dose. Patients will receive AU-007 every two weeks, and the study will determine the best dose to use in future trials.

  • Part 2: This phase will expand on the initial findings to see how well AU-007 works in treating specific types of cancer, such as melanoma, kidney cancer, and non-small cell lung cancer (NSCLC). Other cancers that may be included are head and neck cancer, bladder cancer, stomach cancer, and ovarian cancer.

  • Part 3: This phase will test the safety of combining AU-007 with aldesleukin and another drug called avelumab, focusing on patients with NSCLC.

The study aims to find out if AU-007 can help control cancer growth and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Have cancer that can be measured by scans or tests.
  • Have specific types of cancer that have not responded to standard treatments or cannot tolerate them.
  • For Part 2, include patients with:
    • Kidney cancer that has progressed after at least two treatments.
    • Melanoma that cannot be surgically removed or has spread.
    • NSCLC that is advanced or has spread and is PD-L1 positive.
  • Female patients of childbearing age must have a negative pregnancy test and use two forms of birth control during the study.
  • Male patients must use barrier contraception and ensure their partners use birth control.
  • Patients who have had immune-related side effects from previous treatments must have these resolved to a mild level.
  • Any brain metastases must be treated and stable for at least 14 days before joining the study.

Exclusion Criteria

  • Have a history of autoimmune diseases, except for certain conditions like vitiligo or well-controlled thyroid issues.
  • Have had major surgery or injury within 8 weeks before starting the study.
  • Have unhealed wounds from surgery or injury.
  • Are taking more than 10 mg of prednisone or other immune-suppressive drugs within 7 days before starting the study.
  • Have not recovered from side effects of previous cancer treatments.
  • Have had serious side effects from previous IL-2 therapy.
  • Have unresolved inflammation for more than 4 weeks.
  • Have another invasive cancer that is not in remission for at least 1 year, except for certain non-threatening cancers.

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