Clinical Trials Logo

Clinical Trial Summary

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor.

Clinical Trial Description

The study will include a dose-escalation portion in patients with EGFR-mutated NSCLC who have previously received at least 1 prior EGFR-targeted TKI, followed by expansion groups consisting of patients with tumors harboring specific mutation profiles: EGFR T790M and C797S mutation (Group 1); EGFR T790M but not C797S (Group 2); or EGFR C797S but not T790M (Group 3). ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Antineoplastic Agents
  • Bronchial Neoplasms
  • Carcinoma
  • Carcinoma, Bronchogenic
  • Carcinoma, Non-Small-Cell Lung
  • EGF-R Positive Non-Small Cell Lung Cancer
  • EGFR Activating Mutation
  • EGFR Gene Mutation
  • EGFR T790M
  • Lung Diseases
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Nerve Tissue
  • Protein Kinase Inhibitors
  • Respiratory Tract Disease
  • Respiratory Tract Diseases
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms

NCT number NCT04862780
Study type Interventional
Source Blueprint Medicines Corporation
Contact Blueprint Medicines
Phone 617-714-6707
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date June 30, 2021
Completion date January 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Completed NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT02292641 - The Beyond TME Trial N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Active, not recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT03190811 - Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors Phase 1/Phase 2
Completed NCT02909348 - Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
Not yet recruiting NCT02806557 - Profiling Neutrophil Counts in Patients on Chemotherapy N/A
Recruiting NCT02514512 - Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking Phase 1
Completed NCT02636426 - Sorafenib Administered Using a High-dose, Pulsatile Regimen: a Phase I Exposure Escalation Study Phase 1
Completed NCT01911936 - A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors Phase 1
Completed NCT01915576 - Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients Phase 1
Recruiting NCT01562626 - Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors Phase 1/Phase 2
Completed NCT01688557 - Trial on Innovative Technologies in Colonoscopy N/A
Completed NCT01862198 - The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent Phase 4