NCT05153408

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

A Phase 1/2 Study of the Highly Selective EGFR Inhibitor, BLU-701, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Blueprint Medicines Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was planned to include an initial Phase 1 portion to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BLU-701 as monotherapy (Part 1A; initially in a once daily (QD) regimen with the option to evaluate twice daily (BID) dosing if supported by emerging PK and safety data), as well as additional dose-escalation portions to determine the RP2D of BLU-701 in combination with osimertinib (Part 1B) or in combination with carboplatin and pemetrexed (Part 1C). A Phase 2 part was planned to further evaluate the efficacy and safety of BLU-701 as monotherapy at RP2D (Part 2A). Phase 1 Part 1 A was initiated; however, the study was terminated prior to establishing BLU-701 MTD and/or RP2D.

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

Type	Name	Description
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

Timeline

• Start date: 2022-01-13
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2021-12-10
• Last updated: 2023-06-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study