NCT05241873

(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations

Phase I/II Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (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 study of the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLU-451 monotherapy and BLU-451 in combination with platinum-based chemotherapy (carboplatin and pemetrexed). All participants will receive BLU-451 on a 21-day treatment cycle.

Detailed description

The study is a Phase 1/2 Study of BLU-451 in Advanced Cancers with Epidermal growth factor receptor (EGFR) Exon 20 Insertion Mutations (Ex20ins). The study has two phases: An initial Phase 1 portion will enroll participants with metastatic cancer with EGFR Ex20ins or other selected EGFR mutations that have progressed after prior systemic therapies and will determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BLU-451. Part 1B dose-escalation will enroll participants with metastatic Non-small Cell Lung Cancer (NSCLC) in the USA only to determine the MTD and/or RP2D of BLU-451 in combination with carboplatin and pemetrexed. A Phase 2 portion will further evaluate the efficacy and safety of BLU-451 as monotherapy at RP2D in participants with NSCLC.

Conditions

• Lung Neoplasm Malignant
• Carcinoma, Non-Small-Cell Lung
• Respiratory Tract Neoplasms
• Neoplasms
• Neoplasms by Site
• Lung Diseases
• Respiratory Tract Disease
• Carcinoma, Bronchogenic
• Bronchial Neoplasms
• Adenocarcinoma
• Carcinoma
• Neoplasms by Histologic Type
• EGFR Exon 20 Mutation
• EGFR Exon 20 Insertion Mutation
• EGFR Activating Mutation
• Antineoplastic Agents
• Metastatic Lung Cancer
• Brain Metastases
• EGFR-mutated NSCLC
• EGFR Atypical Mutations, Including G719X and L861Q

Interventions

Type	Name	Description
DRUG	BLU-451	BLU-451 will be administered orally by tablet QD or BID on a 21-day treatment cycle
DRUG	Carboplatin	Carboplatin will be administered intravenously (IV) on Day 1 of each cycle (every 3 weeks) for 4 to 6 cycles
DRUG	Pemetrexed	Pemetrexed will be administered prior to carboplatin as an IV infusion on Day 1 of each cycle (every 3 weeks)

Timeline

• Start date: 2022-03-04
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-02-16
• Last updated: 2025-02-10

Locations

23 sites across 5 countries: United States, Canada, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study