Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
estimated completion
Principal Investigator
by Saeed Sadeghi, MD (ucla)

Description

Summary

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.

Official Title

A Phase 1/1B First-in-Human Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Patients With Advanced Solid Tumors

Details

The first-in-human (FIH) study of BBP-398 will be an open-label, sequential-cohort, non-randomized, Phase 1/1B study utilizing BOIN dose escalation followed by an expansion phase in patients with MAPK pathway- or RTK-driven advanced solid tumors. The primary objective is to determine safety and tolerability of BBP-398, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity, objective response rate (ORR, complete response + partial response rate) and the duration of response (DoR) of BBP-398. The exploratory objective is to assess predictive biomarkers of response.

Keywords

Tumor, Solid, Cancer, MAPK-pathway alterations, BBP-398 (Formerly known as IACS-15509)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC Irvine Health in progress, not accepting new patients
    Orange California 92868 United States
  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Saeed Sadeghi, MD (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 9 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Navire Pharma Inc., a BridgeBio company
ID
NCT04528836
Phase
Phase 1 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated