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EGFR Inhibitor

TAS3351 for Non-Small Cell Lung Cancer (TAS3351 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Locally advanced, non-resectable or metastatic NSCLC
Must have tumor tissue available to allow for analysis of EGFRmt status
Must not have
Have a significant cardiac condition
Unable to swallow or digest pills
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called TAS3351 to see if it is safe and effective for patients with advanced lung cancer that has a specific genetic mutation. The drug works by blocking a protein that helps cancer cells grow.

Who is the study for?
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.
What is being tested?
The study is testing TAS3351's safety and effectiveness when taken orally by patients with NSCLC that has an acquired C797S EGFR mutation. It's a first-in-human study divided into phases: initial dose escalation to find the right dosage followed by expansion and phase II trials focusing on those who meet specific genetic criteria.
What are the potential side effects?
While the exact side effects of TAS3351 are being studied since this is its first trial in humans, potential risks may include typical reactions to oral cancer medications such as nausea, diarrhea, fatigue, liver toxicity, skin rash and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer cannot be removed by surgery and has spread.
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My tumor tissue is available for EGFR mutation testing.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has specific EGFR mutations.
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My cancer has any type of EGFR mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious heart condition.
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I cannot swallow or digest pills.
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I have brain metastases causing symptoms and instability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Dose Expansion: To explore the efficacy of TAS3351
Phase 2: To assess the efficacy of TAS3351
Secondary study objectives
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Dose Escalation: To evaluate the antitumor activity of TAS3351
Dose Escalation:To evaluate the antitumor activity of TAS3351
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: TAS3351 Part C (Phase 2)Experimental Treatment1 Intervention
To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.
Group II: TAS3351 Part B (Dose Expansion)Experimental Treatment1 Intervention
TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.
Group III: TAS3351 Part A (Dose Escalation)Experimental Treatment1 Intervention
Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
78 Previous Clinical Trials
12,840 Total Patients Enrolled

Media Library

TAS3351 (EGFR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05765734 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: TAS3351 Part B (Dose Expansion), TAS3351 Part C (Phase 2), TAS3351 Part A (Dose Escalation)
Non-Small Cell Lung Cancer Clinical Trial 2023: TAS3351 Highlights & Side Effects. Trial Name: NCT05765734 — Phase 1 & 2
TAS3351 (EGFR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05765734 — Phase 1 & 2
~130 spots leftby Dec 2027
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