Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion

Description

Summary

Open-label, Phase 2, single treatment arm, 2 cohorts

Official Title

A Phase 2 Study to Evaluate the Objective Response to Tarloxotinib Administered Intravenously to Patients With Non Small Cell Lung Cancer That Harbors Either EGFR Exon 20 Insertion or a HER2-Activating Mutation

Keywords

NSCLC, Stage IV NSCLC Stage IIIB NSCLC, Stage IIIC NSCLC, Recurrent EGFR Exon 20 Insertion Mutation HER2-activating Mutation Carcinoma, Non-Small-Cell Lung Bromides tarloxotinib bromide

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  • Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV, Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent disease after prior diagnosis of Stage I-III disease
  • Progression of disease on or after a platinum-based chemotherapy regimen
  • EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B)
  • Measurable disease according to RECIST v.1.1
  • ECOG performance status of 0 or 1
  • Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using Cockcroft Gault equation)
  • Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN, in the presence of liver metastases
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
  • Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
  • Platelet count ≥ 100,000/μL
  • No evidence of second or third degree atrioventricular block
  • No clinically significant arrhythmia (i.e.; pauses of > 4 seconds, VT of any duration, SVT > 4 beats/minute)
  • QRS interval ≤ 110 ms
  • QTcF interval of < 450 ms
  • PR interval ≤ 200 ms
  • Adequate pretreatment tumor sample (125 µm of FFPE block or at least 8 prepared slides)

Key Exclusion Criteria:

  • Another known activating oncogene driver mutation
  • Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
  • Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2 antibody drug conjugates
  • Investigational therapy administered within the 28 days or 5 half lives
  • Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1
  • Immunotherapy within 21 days
  • Clinically active or symptomatic interstitial lung disease (ILD) or interstitial pneumonitis, or a history of clinically significant ILD or radiation pneumonitis
  • Untreated and/or symptomatic CNS malignancies (primary or metastatic);
  • Receiving medication that prolongs QT interval, with a risk of causing Torsade de Pointes (TdP)
  • Personal or familial history of Long QT Syndrome
  • NYHA class III or IV or LVEF < 55%
  • Myocardial infarction, severe or unstable angina within 6 months
  • History of TdP, ventricular arrhythmia
  • Significant thrombotic or embolic events within 3 months
  • Uncontrolled or severe cardiovascular disease
  • Concurrent malignancy expected to require treatment within 2 years or interfere with study outcomes
  • History of severe allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition as tarloxotinib
  • Known HIV infection or active Hepatitis B or C

Locations

  • Potential RAIN-701 Study Site accepting new patients
    Irvine California 92697 United States
  • Potential RAIN-701 Study Site not yet accepting patients
    Seattle Washington 98109 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rain Therapeutics Inc.
ID
NCT03805841
Phase
Phase 2
Study Type
Interventional
Last Updated