Status:
TERMINATED
First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors
Lead Sponsor:
Navire Pharma Inc., a BridgeBio company
Conditions:
Tumor, Solid
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 s...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04528836
Start Date
November 12 2020
End Date
July 30 2024
Last Update
December 12 2024
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
City of Hope
Duarte, California, United States, 91010
3
Scripps MD Anderson Cancer Center
La Jolla, California, United States, 92037
4
UC Irvine Health
Orange, California, United States, 92868