Open Actively Recruiting

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

About

Brief Summary

A first-in-human study is 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.

Primary Purpose
Other
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion

  • 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 (excluding BRAF V600X) 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; see Appendix 1).
  • 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 be ≥3 weeks beyond treatment with any chemotherapy or other investigational therapy.
  • Women of childbearing potential (WOCBP) MUST have a negative serum or urine HCG test.
  • 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.

Exclusion Criteria

  • Patients with known active Hepatitis B, Hepatitis C infection, or HIV infection.
  • Patients with active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization. Minor infections are allowed.
  • 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 a history of LVEF <50% within the previous 12 months.
  • Patients with a history of retinal vein occlusion (RVO).
  • Patients with tumors harboring known activating mutations in BRAF V600X, PTPN11 (SHP2) or RAS Q61.
  • Patients with a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Patients with known central nervous system (CNS) tumors.
  • Patients with known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable.
  • Patients who have undergone major surgery within 4 weeks prior to study enrollment.
  • Patients who have previously received a SHP2 inhibitor.
  • Patients with inability to swallow oral medications.
  • Patients should not have gastrointestinal illness that would preclude the absorption of an oral agent.
  • Patients on dialysis.
  • Female patients who are pregnant, planning to become pregnant, or who are breastfeeding.
  • Any patient, who in the opinion of the investigator, is likely to be unable to comply with the study procedures.

Join this Trial

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Study Stats
Protocol No.
21-001055
Category
Hematology-Oncology
Oncology
Contact
BRANDEN BROOKS
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04528836
For detailed technical eligibility, visit ClinicalTrials.gov.