About the study

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

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. 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.
2. Progression of disease on or after a platinum-based chemotherapy regimen (Cohorts A and B) or after standard of care (Cohort C)
3. EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B) or NRG1 or ERBB family gene fusions (Cohort C)
4. Measurable disease according to RECIST v.1.1
5. ECOG performance status of 0 or 1
6. Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using Cockcroft Gault equation)
7. Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases
8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN, in the presence of liver metastases
9. Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
10. Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
11. Platelet count ≥ 100,000/μL
12. No evidence of second or third degree atrioventricular block
13. No clinically significant arrhythmia (i.e.; pauses of > 4 seconds, VT of any duration, SVT > 4 beats/minute)
14. QRS interval ≤ 110 ms
15. QTcF interval of < 450 ms
16. PR interval ≤ 200 ms
17. Adequate pretreatment tumor sample (125 µm of FFPE block or at least 8 prepared slides) Key

Exclusion criteria

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

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.