Status:
TERMINATED
Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions
Lead Sponsor:
Rain Oncology Inc
Conditions:
NSCLC, Stage IV
NSCLC Stage IIIB
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Open-label, Phase 2, single treatment arm, 3 cohorts
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03805841
Start Date
March 13 2019
End Date
April 23 2021
Last Update
June 28 2023
Active Locations (14)
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1
RAIN-701 Study Site
Irvine, California, United States, 92697
2
Pacific Shores Medical Group
Long Beach, California, United States, 90813
3
University of California San Francisco, Helen Diller Cancer Center
San Francisco, California, United States, 94158
4
RAIN-701 Study Site
Aurora, Colorado, United States, 80045