AUBE00 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AUBE00 for individuals with advanced solid tumors. It aims to determine the treatment's safety, how the body processes it, and its potential to reduce tumor size. The study consists of two parts: initially, it tests different doses to establish safety, then it applies those doses to a larger group. Individuals with a KRAS gene change in their cancer who have not responded to standard treatments might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that AUBE00 is likely to be safe for humans?
Research has shown that AUBE00 has been tested in patients with solid tumors to assess its safety and tolerability. Patients have taken varying doses, adjusted to ensure safety, including determining the maximum tolerated dose (MTD), the highest dose without serious side effects.
Studies have found that patients take AUBE00 orally, and researchers closely monitor for any negative effects. Although specific side effects are not detailed, the emphasis on safe dosing indicates careful observation of patient responses.
As this is the first human trial of AUBE00, the primary goal is to understand its safety. Researchers continue to gather information on potential side effects and overall safety. The study includes regular check-ups to detect any issues early.12345Why do researchers think this study treatment might be promising?
Unlike the standard cancer treatments that often involve chemotherapy or radiation, AUBE00 is unique because it’s taken orally and works by targeting specific cancer pathways. Researchers are excited about AUBE00 because it potentially offers a more precise treatment option with fewer side effects than traditional methods. Moreover, AUBE00’s ability to be administered at multiple dose levels allows for flexibility in treatment, which could lead to better customization based on individual patient needs. This innovative approach could transform how we manage and treat cancer, making it a promising option for the future.
What evidence suggests that AUBE00 might be an effective treatment for cancer?
Research shows that AUBE00 is a promising new treatment for patients with solid tumors. Early lab studies have demonstrated AUBE00's potential to effectively target and control tumor growth. Initial data suggest that this pill could help prevent cancer from growing or spreading for a longer time. Although human studies provide limited information, AUBE00 is designed to specifically attack cancer cells, which may lead to better outcomes for patients. The treatment aims to be well-tolerated, with manageable side effects. Participants in this trial will receive AUBE00 in different parts: Part A involves dose escalation to determine safe levels, and Part B involves expansion at multiple dose levels, including the maximum tolerated dose (MTD).23467
Who Is on the Research Team?
Sponsor Chugai Pharmaceutical Co.Ltd
Principal Investigator
clinical-trials@chugai-pharm.co.jp
Are You a Good Fit for This Trial?
This trial is for people with advanced or widespread solid tumors. Around 70 to 100 patients will be accepted. Specific eligibility details are not provided, but typically participants must meet certain health standards and have a type of tumor that the study targets.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients receive AUBE00 as an oral administration at escalated doses to determine the maximum tolerated dose (MTD)
Dose Expansion
Patients receive AUBE00 at multiple dose levels determined to be safe, including the MTD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AUBE00
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chugai Pharmaceutical
Lead Sponsor
Dr. Osamu Okuda
Chugai Pharmaceutical
Chief Executive Officer since 2020
MD from Kyoto University
Dr. Mariko Y. Momoi
Chugai Pharmaceutical
Chief Medical Officer
MD from Jichi Medical University