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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Navire Pharma Inc., a BridgeBio company
Study ID
NCT04528836
Phase
PHASE1
Status
Terminated

Conditions

  • Tumor, Solid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 12, 2020
Status verified
Dec 2024
Primary completion
Mar 22, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Experimental: 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

Primary Outcome Measure

Determination of Maximum Tolerated Dose (MTD) and establish the RP2D of BBP-398. [ Time Frame: Completion of 1 Cycle ( 28 days) ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
City of HopeDuarteCalifornia91010-
Scripps MD Anderson Cancer CenterLa JollaCalifornia92037-
UC Irvine HealthOrangeCalifornia92868-
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404-
Sarah Cannon Research InstituteDenverColorado80218-
The University of Texas MD Anderson Cancer CenterHoustonTexas77096-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
NEXT VirginiaFairfaxVirginia22031-
MultiCare Institute for Research & InnovationTacomaWashington98405-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CAScripps MD Anderson Cancer Center· La Jolla, CAUC Irvine Health· Orange, CAUCLA Hematology/Oncology - Santa Monica· Santa Monica, CASarah Cannon Research Institute· Denver, CO

Related Studies