Phase I Study of the BBP-398 in Patients With Advance Solid Tumors

This is an open label, dose escalation and expansion, two-part Phase I study for SHP-2 inhibitor BBP-398 to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and preliminary anti- cancer activity in Chinese subjects with advanced solid tumors and in Chinese subjects with advanced or metastatic EGFR-mutant NSCLC.

Inclusion Criteria:1. Patients must have the ability to understand and the willingness to sign a written informed consent document 2 Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures 3. Age ≥18, male or female 4.Dose escalation: locally advanced or metastatic solid tumors Dose expansion: Advanced or metastatic EGFR-mutant NSCLC 5. Patients must have measurable disease by RECIST v1.1. 6. Patients must have an ECOG performance status (PS) ≤2 7.Patients with a life expectancy of ≥12 weeks. 8. Patients must have adequate organ functionExclusion Criteria:Patients with a known additional malignancy that is progressing or requires active treatmentPatients who have previously received a SHP-2 inhibitorPatients who are hypersensitivity to SHP-2 inhibitor or any ingredientsTreatment with any of the related anti-cancer therapies prior to the first dose of BBP-398 within the stated timeframesPatients with known active Hepatitis B, Hepatitis C infection, or HIV infection.Patients with any of the cardiac-related issues or findingsPatients with a history of CVA, myocardial infarction or unstable angina within the previous 6 months before starting therapy.Patients with known central nervous system (CNS) tumorsPatients with known active CNS metastases and/or carcinomatous meningitis.Patients with persisting toxicity related to prior therapy.Patients who have undergone major surgery within 4 weeks prior to study enrollment.Pregnant or breastfeeding female patients.Patients with inability to swallow oral medications or with gastrointestinal illness that would preclude the absorption of an oral agent.