First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI

Exclusion Criteria

• •1. Has symptomatic brain or spinal cord metastases with exceptions.
• •2. Any of the following cardiac conditions within the last 6 months from the first dose of study treatment:
• •1. Unexplained or cardiovascular cause of presyncope or syncope, tachycardia, ventricular fibrillation, or sudden cardiac arrest.
• •2. Prolonged corrected QT interval (mean resting corrected QT interval using Fridericia's formula \[QTcF\] \>470 msec from 3 ECGs).
• •3. Clinically significant, uncontrolled, cardiovascular disease including congestive heart failure grade 3 or 4 according to the New York Heart Association classification; myocardial infarction or unstable angina, uncontrolled hypertension, or clinically significant, uncontrolled arrhythmias, including bradyarrhythmia that may cause QT prolongation (eg, Type II second degree heart block or third-degree heart block).
• •\<Prior or Concomitant Anticancer Therapy\>
• •3. An EGFR TKI, including but not limited to osimertinib, afatinib, dacomitinib, gefitinib, or erlotinib within 8 days of the first dose of study treatment.
• •4. Small molecule targeted inhibitor other than EGFR inhibitor class or cytotoxic chemotherapy within 14 days, or biologic anticancer medicine (cytokines or antibodies, etc.) within 28 days (before the initiation of BBT-207 treatment) for the systemic treatment of advanced NSCLC.
• •5. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy.
• •6. Has had radiotherapy within 14 days before the initiation of study treatment. Note: Palliative radiotherapy for pain can be administered at any time before the first dose of study treatment.