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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

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

NCT number NCT05241873
Study type Interventional
Source Blueprint Medicines Corporation
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date March 4, 2022
Completion date July 25, 2026

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