First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors

Key Inclusion Criteria

• Male and non-pregnant females >18 years old.

• Patients must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with MAPK-pathway alterations as assessed by clinically validated and/or FDA-approved molecular diagnostic and no available standard of care or curative therapies (MAPK-pathway alterations include, for example KRASG12C mutant, EGFR-mutant).

• Dose expansion only: Patients with specific genomically defined tumor types will be recruited.

• Patients must have measurable disease by RECIST v1.1.

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.

• Patients must have adequate organ function.

• Patients must have the ability to understand and the willingness to sign a written informed consent document prior to the initiation of the study and any study procedures.

• Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.

Key Exclusion Criteria

• Patients with known active Hepatitis B, Hepatitis C infection, or HIV infection.

• Patients with a history of CVA, myocardial infarction or unstable angina within the previous 6 months before starting therapy.

• Patients with clinically significant cardiac disease.

• Patients with tumors harboring known activating mutations.

• Patients with a known additional malignancy that is progressing or requires active treatment.

• Patients with known central nervous system (CNS) tumors.

• Patients with known active CNS metastases and/or carcinomatous meningitis.

• Patients who have previously received a SHP2 inhibitor.

• Patients with inability to swallow oral medications or with gastrointestinal illness that would preclude the absorption of an oral agent.

• Patients on dialysis.

• Patients with a life expectancy of ≤12 weeks after the start of IP according to the investigator's judgement.

• Patients with known intolerance/hypersensitivity to BBP-398 or its excipients.