(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Blueprint Medicines Corporation
Study ID
NCT05153408
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 C797A
  • EGFR C797G
  • EGFR C797S
  • EGFR C797X
  • EGFR Exon 19 Deletion
  • EGFR Gene Mutation
  • EGFR L858R
  • EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance
  • Lung Diseases
  • Lung Neoplasm
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Nerve Tissue
  • Non Small Cell Lung Cancer
  • Protein Kinase Inhibitors
  • Respiratory Tract Diseases
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms

Eligibility Criteria

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

Interventions

  • BLU-701 — DRUG
    BLU-701 for oral administration
  • osimertinib — DRUG
    Osimertinib tablets for oral administration
  • carboplatin — DRUG
    IV infusion of carboplatin
  • pemetrexed — DRUG
    IV infusion of pemetrexed

Study Details

This is a Phase 1/2, open-label, first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BLU-701 as monotherapy or in combination with either osimertinib or platinum-based chemotherapy in patients with EGFRm NSCLC.

Key Dates

Start date
Jan 13, 2022
Status verified
Jun 2023
Primary completion
Dec 9, 2022
Completion
Dec 9, 2022

Study Design

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

Arms

  • Experimental: Part 1A: BLU-701 as monotherapy
    Phase 1 dose escalation of BLU-701 as monotherapy at various dose levels
  • Experimental: Part 1B: BLU-701 with osimertinib
    BLU-701 in combination with osimertinib 40 mg or 80 mg tablets for oral administration
  • Experimental: Part 1C: BLU-701 with platinum-based chemotherapy
    BLU-701 in combination with platinum-based chemotherapy (carboplatin and pemetrexed): Carboplatin - IV infusion dosed to target AUC of 5-6 mg/mL min q3w Pemetrexed - IV infusion dosed to 500 mg/m2 q3w
  • Experimental: Part 2A: BLU-701 as monotherapy
    Phase 2 expansion group for BLU-701 as monotherapy at a dose determined during Part 1A in patients harboring the EGFR C797X resistance mutation

Primary Outcome Measure

[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-701 monotherapy, BLU-701 in combination with osimertinib, and BLU-701 in combination with platinum-based chemotherapy [ Time Frame: Up to 12 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford HospitalDetroitMichigan48202-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
New York University (NYU) Langone Medical CenterNew YorkNew York10016-
Sarah Cannon Research InstituteNashvilleTennessee37203-
NEXT VirginiaFairfaxVirginia22031-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Dana-Farber Cancer Institute· Boston, MAHenry Ford Hospital· Detroit, MIMemorial Sloan Kettering Cancer Center· New York, NYNew York University (NYU) Langone Medical Center· New York, NYSarah Cannon Research Institute· Nashville, TNNEXT Virginia· Fairfax, VA

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