Description:
Open-label, Phase 2, single treatment arm, 3 cohorts
Open-label, Phase 2, single treatment arm, 3 cohorts
Recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| tarloxotinib bromide | Tarlox, tarloxotinib | Active |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Active | Experimental | tarloxotinib bromide |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | ORR |
| Time Frame: | through study completion, an average of 10 months |
| Safety Issue: | |
| Description: | Objective Response Rate (number of subjects with PR or CR) |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Rain Therapeutics Inc. |
August 12, 2020