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A Phase 1 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

Clinical Trial Details

This is a phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, effectiveness of BLU-667 administered orally in patients. The aim of the study is to determine the maximum tolerated dose and recommended phase 2 dose of BLU-667. 

The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2). Both parts will enroll patients with advanced non-resectable non-small cell lung cancer (NSCLC), advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have not adequately responded to standard systemic therapy, or are in patients who are intolerant to or have declined standard therapy.    

  • Patients are anticipated to receive at least 1 treatment cycle, which is 28 days. 
  • All patients will attend an End-Of-Treatment visit approximately 14 (give or take 7 days) after the last dose of study drug. 
  • Will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. 
Key Eligibility: 
  • Open to women and men age 18 and older 
  • Diagnosis pathologically documented, definitively diagnosed as non-resectable advanced solid tumor (e.g. thyroid, non small cell lung, colon) 
  • Patient must have non-resectable disease that has progressed following standard therapy or has not adequately responded to standard therapy, or the patient must be intolerant to available standard therapies, or there must be no accepted standard therapy for their disease
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Alice Mercado, RN, MBA, CCRC
(646) 962-3080
alm2051@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1711018786

ClinicalTrials.gov:

NCT03037385

Status

Open to Enrollment

Age Group

Adult

Sponsor