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

NCT05241873 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-02-10

No results posted yet for this study

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.

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

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)

Sponsors & Collaborators

  • Blueprint Medicines Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-04
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
Diseases

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 NCT05241873 on ClinicalTrials.gov