Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSF
Dates
study started
estimated completion
Principal Investigator
Caroline McCoach, MD (ucsf)
Photo of Caroline McCoach
Caroline McCoach

Description

Summary

Open-label, Phase 2, single treatment arm, 3 cohorts

Official Title

Phase 2 Study - Evaluate the Clinical Activity of Tarloxotinib in Patients With Non-Small Cell Lung Cancer That Harbors an EGFR Exon 20 Insertion or HER2-Activating Mutation and Other Advanced Solid Tumors With NRG1/ERBB Family Gene Fusions

Keywords

NSCLC, Stage IV NSCLC Stage IIIB NSCLC, Stage IIIC NSCLC, Recurrent EGFR Exon 20 Insertion Mutation HER2-activating Mutation ERBB Fusion NRG1 Fusion 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. Cohort C locally advanced or metastatic solid tumor.
  • Progression of disease on or after a platinum-based chemotherapy regimen (Cohorts A and B) or after standard of care (Cohort C)
  • EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B) or NRG1 or ERBB family gene fusions (Cohort C)
  • 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
  • (Cohorts A and B Only) Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
  • (Cohorts A and B Only) 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

  • University of California San Francisco, Helen Diller Cancer Center accepting new patients
    San Francisco California 94158 United States
  • RAIN-701 Study Site accepting new patients
    Irvine California 92697 United States

Lead Scientist at UC Health

  • Caroline McCoach, MD (ucsf)
    Caroline McCoach is a thoracic oncologist who focuses on the treatment of patients with lung cancer as well as other thoracic malignancies. Her goal is to provide a personalized approach to treatment, based on each patient’s cancer type in combination with their individual treatment goals.

Details

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