ATI-2231 for Solid Tumor Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ATI-2231, for individuals with advanced solid tumor cancers such as head and neck, lung, and breast cancer, where other treatments have failed. The primary goal is to determine the safest dose for future studies. Participants will receive ATI-2231 alone to assess how the body processes it. Suitable candidates have a solid tumor cancer unresponsive to other treatments and access to a past biopsy sample from their cancer. As a Phase 1 trial, this research aims to understand how ATI-2231 works in people, offering participants the chance to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial requires stopping certain medications before starting, such as denosumab or bisphosphonates (4 weeks), radiation therapy (1 week), systemic chemotherapy (3 weeks), and immunotherapy (3 weeks). However, endocrine therapies can be continued until the first day of the trial.
Is there any evidence suggesting that ATI-2231 is likely to be safe for humans?
Research has shown that ATI-2231 is under careful observation for safety in patients with advanced solid tumors. This treatment is in the early testing stages, so researchers are primarily assessing patient tolerance. During this phase, they closely monitor any side effects or adverse reactions to ensure patient safety. As this is the first human trial, detailed safety information is not yet available. However, the emphasis on safety ensures that any serious issues are quickly identified and addressed. Joining a clinical trial involves some risk, so discussing potential side effects with the trial team is important.12345
Why do researchers think this study treatment might be promising?
ATI-2231 is unique because it introduces a novel chemical compound specifically designed to target solid tumor cancers. Unlike traditional chemotherapy drugs that often attack rapidly dividing cells indiscriminately, ATI-2231 aims to provide a more targeted approach, potentially reducing side effects and improving patient outcomes. Researchers are excited about ATI-2231 because it offers a new mechanism of action that might work where other treatments have been less effective, giving hope for more personalized and effective cancer therapies.
What evidence suggests that ATI-2231 might be an effective treatment for solid tumor cancers?
Research shows that ATI-2231, administered as monotherapy in this trial, is a pill targeting a protein linked to tumor growth. This drug aims to slow or stop the growth of cancer cells in solid tumors. Early results suggest it might be effective for cancers such as pancreatic and metastatic breast cancer. Although human data remains limited, the drug's action on specific proteins shows promise in preventing cancer spread. While still in early stages, the science behind ATI-2231 appears hopeful for combating difficult cancers.12346
Who Is on the Research Team?
Cynthia X Ma, M.D., Ph.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ATI-2231 monotherapy at assigned dose levels, with each cycle lasting 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ATI-2231
- Bisphosphonate
- Capecitabine
- Denosumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
United States Department of Defense
Collaborator
Aclaris Therapeutics, Inc.
Industry Sponsor