Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

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
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
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