BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations

An Open-label, Non-randomized, Multi-cohort, Multi-center Phase Ia/Ib Study Evaluating the Efficacy and Safety of BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations

This is an open-label, non-randomized, multi-cohort, multi-center Phase Ia/Ib study for BBP-398 in combination with Osimertinib to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and anti-cancer activity in locally advanced or metastatic NSCLC patients with EGFR mutations and with previously 3rd generation EGFR-TKIs treated or EGFR-TKI-naive.

Inclusion Criteria:

• Patients must have the ability to understand and the willingness to sign a written informed consent document.
• Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.
• Age ≥18, male or female.
• Patients are not suitable for surgical resection and must have histologically or cytologically confirmed advanced or metastatic NSCLC with documented EGFR sensitivity mutation (at any time since the initial diagnosis of NSCLC) to confirm susceptibility to EGFR-TKI therapy.
• Patients must have measurable disease by RECIST v1.1.
• ECOG performance status ≤2.
• Patients must have a life expectancy of ≥12 weeks as estimated at the time of screening.
• Patients must have adequate organ function.

Exclusion Criteria:

• Patients with a known additional malignancy that is progressing or requires active treatment.
• Patients who have previously received a SHP-2 inhibitor.
• Patients who are hypersensitivity to BBP-398/ Osimertinib or active or inactive excipients.
• Treatment with any of the following anti-cancer therapies prior to the first dose within the stated timeframes.
• Pregnant or breastfeeding female patients.
• Patients with untreated symptomatic brain metastases and/or meningeal metastases.