Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions
a study on Non-Small Cell Lung Cancer EGFR Exon 20 Insertion Mutation HER2 ERBB Fusion NRG1 Fusion Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Irvine, California and other locations
- Dates
- study startedestimated completion
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
You can join if…
Open to people ages 18 years and up
- 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)
You CAN'T join if...
- 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
- RAIN-701 Study Site
accepting new patients
Irvine California 92697 United States - Pacific Shores Medical Group
accepting new patients
Long Beach California 90813 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
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