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

NCT05153408 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-06-18

No results posted yet for this 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.

Conditions

  • Lung Neoplasm
  • Carcinoma, Non-Small-Cell Lung
  • Respiratory Tract Neoplasms
  • Neoplasms
  • Neoplasms by Site
  • Lung Diseases
  • Respiratory Tract Diseases
  • Carcinoma, Bronchogenic
  • Bronchial Neoplasms
  • Adenocarcinoma
  • Carcinoma
  • Neoplasms by Histologic Type
  • Neoplasms, Nerve Tissue
  • EGFR C797S
  • EGFR C797A
  • EGFR L858R
  • EGFR Exon 19 Deletion
  • EGFR Gene Mutation
  • EGF-R Positive Non-Small Cell Lung Cancer
  • EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance
  • EGFR Activating Mutation
  • Thoracic Neoplasms
  • Antineoplastic Agents
  • Protein Kinase Inhibitors
  • EGFR C797G
  • EGFR C797X
  • Non Small Cell Lung Cancer

Interventions

DRUG

BLU-701

BLU-701 for oral administration

DRUG

osimertinib

Osimertinib tablets for oral administration

DRUG

carboplatin

IV infusion of carboplatin

DRUG

pemetrexed

IV infusion of pemetrexed

Sponsors & Collaborators

  • Blueprint Medicines Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2022-12-09
Completion
2022-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153408 on ClinicalTrials.gov