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Small Molecule Drug

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

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

No Placebo-Only Group

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 Mutations
Lung Cancer
Cancer
Neoplasm
Neurofibromatosis
Acute Viral Respiratory Infection
Thoracic Tumors
Non-Small Cell Lung Cancer
Lung Disease
Adenocarcinoma
Epidermal Growth Factor Receptor Deletion
Respiratory Tract Neoplasms
Benign Respiratory Tract Tumor
Bronchial Adenoma
Protein Kinase Inhibitors
Epidermal Growth Factor Receptor
Tyrosine Kinase Inhibitor Resistance
Chemotherapy
Bronchial Tumors
Tumors
Respiratory Diseases

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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