(SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC

Part of paid clinical trials in La Jolla, California.

Sponsor
Blueprint Medicines Corporation
Study ID
NCT04862780
Phase
PHASE1
Status
Terminated

Conditions

  • 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 C797S
  • EGFR Exon 19 Deletion
  • EGFR Gene Mutation
  • EGFR L858R
  • EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance
  • 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 Neoplasms
  • Thoracic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BLU-945 — DRUG
    Oral administration
  • osimertinib — DRUG
    Osimertinib tablets for oral administration

Study Details

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, as monotherapy or in combination with osimertinib.

Key Dates

Start date
Jun 29, 2021
Status verified
Feb 2025
Primary completion
Oct 7, 2024
Completion
Oct 7, 2024

Study Design

Enrollment
177 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: BLU-945 as monotherapy
    Phase 1 dose escalation of BLU-945 as monotherapy at various dose levels
  • Experimental: Part 1B: BLU-945 with osimertinib
    Phase 1 dose escalation of BLU-945 in combination with osimertinib 80 mg tablets for oral administration
  • Experimental: Phase 2, Group 1: BLU-945 as monotherapy
    Phase 2 expansion group for BLU-945 as monotherapy at a dose determined during Part 1A in patients with EGFR T790M and C797S mutations
  • Experimental: Phase 2, Group 2: BLU-945 as monotherapy
    Phase 2 expansion group for BLU-945 as monotherapy at a dose determined during Part 1A in patients with EGFR T790M mutations
  • Experimental: Phase 2, Group 3: BLU-945 as monotherapy
    Phase 2 expansion group for BLU-945 as monotherapy at a dose determined during Part 1A in patients with EGFR C797S mutations
  • Experimental: Phase 2, Group 4: BLU-945 with osimertinib
    Phase 2 expansion group for BLU-945 with osimertinib at a dose determined during Part 1B in patients

Primary Outcome Measure

[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib [ Time Frame: Up to 12 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
UC Irvine Health, Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)AuroraColorado80045-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NYU Langone Health, Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-
Sarah Cannon Research InstituteNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UC San Diego Moores Cancer Center· La Jolla, CACedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CAUC Irvine Health, Chao Family Comprehensive Cancer Center· Orange, CAUniversity of Colorado Hospital - Anschutz Cancer Pavilion (ACP)· Aurora, CODana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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