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NCT05153408 · ClinicalTrials.gov registry record · Phase 1

(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC

A Phase 1 study, sponsored by Blueprint Medicines Corporation.

Terminated
Registry status
Phase 1
Development phase
20
Enrollment target

NCT05153408: Clinical Trial Phase 1 study, sponsored by Blueprint Medicines Corporation.

NCT05153408 is a Phase 1 study that was terminated before completion, run by Blueprint Medicines Corporation. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05153408, a Phase 1 study, was terminated before completion, sponsored by Blueprint Medicines Corporation.

TERMINATED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

This is a Phase 1/2, open-label, first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BLU-701 as monotherapy or in combination with either osimertinib or platinum-based chemotherapy in patients with EGFRm NSCLC.

Primary Outcome

MTD determination: dose limiting toxicity (DLT) rate

Interventions

  • DRUG osimertinib
  • DRUG carboplatin
  • DRUG pemetrexed
  • DRUG BLU-701

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-01-13
Est. Completion 2022-12-09
Phase Phase 1
Blueprint Medicines Corporation

24 total trials

Why NCT05153408 stopped before completion

NCT05153408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 4 interventions - of which osimertinib is the first listed.

NCT05153408 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05153408 about?

NCT05153408 is a clinical study titled "(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC". This is a Phase 1/2, open-label, first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BLU-701 as monotherapy or in combination with either osimertinib or platinum-based chemotherapy in patients with EGFRm NSCLC.

What is the current status of trial NCT05153408?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-01-13. Estimated completion is 2022-12-09.

What interventions are being tested in trial NCT05153408?

The interventions under investigation include: osimertinib (DRUG), carboplatin (DRUG), pemetrexed (DRUG), BLU-701 (DRUG).

Who is sponsoring clinical trial NCT05153408?

This trial is sponsored by Blueprint Medicines Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05153408's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 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 NCT05153408, the US trial registry maintained by the National Library of Medicine. NCT05153408 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.