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.