Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active
tarloxotinib bromide
  • Drug: tarloxotinib bromide
    weekly intravenous infusion
    Other names:
    • Tarlox
    • tarloxotinib

More Details

Status
Terminated
Sponsor
Rain Oncology Inc

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.