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NCT05765734 · ClinicalTrials.gov registry record · Phase 1

A Study of TAS3351 in NSCLC Patients With EGFRmt

A Phase 1 study, sponsored by Taiho Oncology.

Terminated
Registry status
Phase 1
Development phase
18
Enrollment target

NCT05765734: Clinical Trial Phase 1 study, sponsored by Taiho Oncology.

NCT05765734 is a Phase 1 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05765734, a Phase 1 study, was terminated before completion, sponsored by Taiho Oncology.

TERMINATED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in participants with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

Primary Outcome

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug and did not necessarily have a causal relationship to the use of the study drug.

Interventions

  • DRUG TAS3351

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2023-05-25
Est. Completion 2025-03-14
Phase Phase 1
Taiho Oncology

52 total trials

Why NCT05765734 stopped before completion

NCT05765734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which TAS3351 is the first listed.

NCT05765734 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05765734 about?

NCT05765734 is a clinical study titled "A Study of TAS3351 in NSCLC Patients With EGFRmt". This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in participants with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

What is the current status of trial NCT05765734?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-05-25. Estimated completion is 2025-03-14.

What interventions are being tested in trial NCT05765734?

The interventions under investigation include: TAS3351 (DRUG).

Who is sponsoring clinical trial NCT05765734?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05765734's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05765734, the US trial registry maintained by the National Library of Medicine. NCT05765734 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.