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Small Molecule Drug

BLU-701 for Epidermal Growth Factor Receptor

Phase 1
Waitlist Available
Research Sponsored by Blueprint Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights

Summary

This trial is testing a new drug, BLU-701, for patients with a specific type of lung cancer that is hard to treat. The drug aims to stop cancer cells from growing by targeting their mutations. The study was stopped before finding the best dose.

Eligible Conditions
  • Epidermal Growth Factor Receptor
  • Epidermal Growth Factor Receptor Mutations
  • Epidermal Growth Factor Receptor Deletion
  • Protein Kinase Inhibitors
  • Lung Disease
  • Non-Small Cell Lung Cancer
  • Tyrosine Kinase Inhibitor Resistance
  • Lung Cancer
  • Bronchial Tumors
  • Adenocarcinoma
  • Chemotherapy
  • Tumors
  • Cancer
  • Neurofibromatosis
  • Respiratory Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
[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
[Phase 1] Determine the recommended Phase 2 dose (RP2D) of BLU-701 monotherapy, BLU-701 in combination with osimertinib, and BLU-701 in combination with platinum-based chemotherapy
[Phase 1] Overall safety profile
+1 more
Secondary study objectives
[Phase 1 and Phase 2] Duration of response (DOR)
[Phase 1 and Phase 2] To characterize the PK profile of BLU-701
[Phase 1] Overall response rate (ORR)
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2A: BLU-701 as monotherapyExperimental Treatment1 Intervention
Phase 2 expansion group for BLU-701 as monotherapy at a dose determined during Part 1A in patients harboring the EGFR C797X resistance mutation
Group II: Part 1C: BLU-701 with platinum-based chemotherapyExperimental Treatment3 Interventions
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
Group III: Part 1B: BLU-701 with osimertinibExperimental Treatment2 Interventions
BLU-701 in combination with osimertinib 40 mg or 80 mg tablets for oral administration
Group IV: Part 1A: BLU-701 as monotherapyExperimental Treatment1 Intervention
Phase 1 dose escalation of BLU-701 as monotherapy at various dose levels
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
osimertinib
2023
Completed Phase 2
~160
carboplatin
2010
Completed Phase 3
~4790
pemetrexed
2005
Completed Phase 3
~5000

Find a Location

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
6,188 Total Patients Enrolled
~5 spots leftby Sep 2025
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