First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors
NCT ID: NCT04528836
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
72 participants
INTERVENTIONAL
2020-11-12
2024-07-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
BBP-398 (Formerly known as IACS-15509)
oral capsules
Dose Expansion
Oral capsules administered at MTD/RP2D defined dose. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
* Cohort A: Advanced or metastatic KRAS mutant solid tumor
* Cohort B: Advanced solid tumor with NF1 loss-of-function (LOF) or metastatic BRAF class II/III mutant solid tumor
BBP-398 (Formerly known as IACS-15509)
oral capsules
Interventions
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BBP-398 (Formerly known as IACS-15509)
oral capsules
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Navire Pharma Inc., a BridgeBio company
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
Scripps MD Anderson Cancer Center
La Jolla, California, United States
UC Irvine Health
Orange, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Countries
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Other Identifiers
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NAV-1001
Identifier Type: -
Identifier Source: org_study_id