Open Actively Recruiting
First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, 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 the following 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. Food Effect (FE) Cohort of the Sub-study Only: Patients who have a diet incompatible with the on-study diet, in the opinion of the investigator.
Join this Trial
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