TAS3351 for Non-Small Cell Lung Cancer
(TAS3351 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and effectiveness of a new treatment, TAS3351, for individuals with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation in the cancer's DNA. The trial consists of three parts: initially, it tests various doses to determine the optimal one; then it expands to include more participants to assess the treatment's effects; and finally, it further evaluates the treatment's effectiveness. Suitable candidates have NSCLC that is inoperable and contains a C797S mutation in the EGFR gene. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
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 TAS3351 is likely to be safe for humans?
Research shows that TAS3351 is a promising new treatment being tested for safety in people with advanced non-small cell lung cancer (NSCLC) who have a specific gene change called the C797S EGFR mutation. Since this is the first time TAS3351 is tested in humans, existing data is limited. However, researchers closely monitor how well people handle TAS3351 and what side effects might occur.
In studies like this, safety is the top priority. The study adjusts the dosage to find the safest and most effective amount for people to take. While specific data on side effects or tolerance is not yet available, the early phase of the trial indicates that researchers are still collecting important safety information.
It's important to know that TAS3351 is not yet approved for any use, so its safety profile is still being developed through this ongoing research. Trial participants will be closely monitored to ensure their safety and to gather more data on how TAS3351 affects them.12345Why do researchers think this study treatment might be promising for non-small cell lung cancer?
Unlike the standard treatments for non-small cell lung cancer, which often involve chemotherapy, immunotherapy, or targeted therapies like EGFR inhibitors, TAS3351 acts on a specific mutation known as C797S EGFRmt. This mutation can make cancer resistant to current EGFR-targeted drugs, but TAS3351 aims to overcome this resistance by targeting it directly. Researchers are excited about TAS3351 because it represents a new approach, potentially offering more effective treatment for patients with this difficult-to-treat mutation.
What evidence suggests that TAS3351 might be an effective treatment for non-small cell lung cancer?
Research has shown that TAS3351 is a promising treatment for non-small cell lung cancer (NSCLC) with a specific change known as the C797S EGFR mutation. This mutation often causes resistance to current treatments. TAS3351, a new type of drug called a tyrosine kinase inhibitor (TKI), targets certain proteins in cancer cells to halt their growth. Notably, TAS3351 can reach the brain, potentially benefiting patients whose cancer has spread there. While researchers continue to gather information about TAS3351, it is designed to target resistance mutations, suggesting it could succeed where other treatments fail. Participants in this trial will receive TAS3351 in different phases to evaluate its safety and efficacy.14678
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have a specific mutation called C797S in the EGFR gene. Participants must be able to perform daily activities with little to no assistance (ECOG performance status of 0 or 1), have tumor tissue available for analysis, and their major organs must function well. They should not be part of other conflicting studies, have unstable brain metastases, unresolved effects from past cancer treatments, significant heart issues, or conditions preventing pill ingestion.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally
Dose Expansion
The dose expansion part will explore the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations
Phase 2
The phase 2 part will assess the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TAS3351
Find a Clinic Near You
Who Is Running the Clinical Trial?
Taiho Oncology, Inc.
Lead Sponsor
Tim Whitten
Taiho Oncology, Inc.
Chief Executive Officer since 2018
MBA and Pharmacy degree
Harold Keer
Taiho Oncology, Inc.
Chief Medical Officer
MD, PhD