ASP4396 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment, ASP4396, for solid tumors in individuals with a specific mutation (G12D) in the KRAS gene. Researchers seek to determine the safety of ASP4396, how the body processes it, and the optimal dose. The trial includes two phases: initially, testing various doses to assess tolerance, followed by confirming the best dose. Eligible participants have advanced or metastatic cancer with the specific KRAS mutation and have either tried or declined standard treatments. Participants will receive the treatment through an infusion every 21 days and will be monitored closely. As a Phase 1 trial, the 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. However, if you are expected to require another form of anticancer therapy, you may not be eligible to participate.
Is there any evidence suggesting that ASP4396 is likely to be safe for humans?
Research shows that ASP4396 has not yet been tested in humans. However, lab studies on cells and animals have shown promising results in stopping cancer growth, especially in cases with the KRAS G12D mutation.
As ASP4396 is being given to humans for the first time, researchers are closely monitoring for any health issues. The study aims to find a safe dose and assess how well people tolerate the treatment. While no data exists yet on human reactions, the early phase focuses on evaluating safety. Researchers are just beginning to understand how well people can handle ASP4396.12345Why do researchers think this study treatment might be promising?
Most treatments for solid tumors focus on traditional methods like surgery, chemotherapy, and radiation, which target the tumor itself or rapidly dividing cells in general. ASP4396 is unique because it potentially introduces a novel mechanism of action specifically designed to target pathways that are not addressed by current therapies. Researchers are excited about ASP4396 because it offers the possibility of a more precise approach, potentially reducing side effects and improving outcomes for patients. By focusing on unique biological markers within solid tumors, ASP4396 could provide a more tailored treatment option, setting it apart from existing therapies.
What evidence suggests that ASP4396 might be an effective treatment for solid tumors with the G12D mutation?
Research shows that ASP4396 targets solid tumors with the KRAS G12D mutation. Lab studies have demonstrated that ASP4396 breaks down the abnormal proteins produced by this mutation, helping to stop tumor growth. This treatment is currently undergoing its first human trial. Participants will receive ASP4396 in either a dose escalation or dose expansion phase, both conducted in 21-day cycles. Early results from lab models have been promising, showing strong anti-tumor effects. Although human data remains limited, its mechanism suggests potential effectiveness for these tumors.25678
Who Is on the Research Team?
Central Contact
Principal Investigator
Astellas Pharma Inc
Are You a Good Fit for This Trial?
Adults with advanced solid tumors that can't be removed by surgery or have spread to other body parts, and who have a specific gene change (KRAS G12D mutation). They should have tried standard treatments or declined them, be able to do daily activities with little help (ECOG status 0-1), and their organs must work well.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of ASP4396 to determine safety and suitable dose levels
Dose Expansion
Participants receive ASP4396 at doses determined from the Dose Escalation phase to refine dosing accuracy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASP4396
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Inc
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy