(VELA) Study of BLU-222 in Advanced Solid Tumors

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Blueprint Medicines Corporation
Study ID
NCT05252416
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • BLU-222 — DRUG
    Oral administration
  • Carboplatin — DRUG
    IV Infusion
  • Ribociclib — DRUG
    Oral administration
  • Fulvestrant — DRUG
    Intra muscular administration

Study Details

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.

Key Dates

Start date
Apr 7, 2022
Status verified
Nov 2025
Primary completion
Jul 4, 2025
Completion
Jul 4, 2025

Study Design

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

Arms

  • Experimental: BLU-222 Monotherapy
    Dose Escalation: Multiple doses for BLU-222 for oral administration Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation
  • Experimental: BLU-222 + Carboplatin
    Dose Escalation: Multiple doses for BLU-222 for oral administration at doses deemed appropriate based on BLU-222 Monotherapy arm and multiple doses of Carboplatin at the approved dose. Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation and Carboplatin IV infusion at approved dose
  • Experimental: BLU-222 + Ribociclib + Fulvestrant
    Dose Escalation: Multiple doses for BLU-222 for oral administration at doses deemed appropriate based on BLU-222 Monotherapy arm along with Ribociclib and Fulvestrant at the approved doses. Dose Expansion: Oral dose of BLU-222 as determined during dose escalation and approved doses of Ribociclib and Fulvestrant
  • Experimental: BLU-222 + Fulvestrant
    Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation + fulvestrant at the approved dose

Primary Outcome Measure

[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-222 [ Time Frame: Approximately 21 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Stanford Women's Cancer CenterStanfordCalifornia94305-
Florida Cancer SpecialistsSarasotaFlorida34232-
University of Chicago Medical CenterChicagoIllinois60637-
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC)BaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Columbia University Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Montefiore Medical CenterNew YorkNew York10461-
UNC Hospitals at Chapel Hill - The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Hospital of the Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Vanderbilt Breast Center at One Hundred OaksNashvilleTennessee37204-
MD Anderson Cancer CenterHoustonTexas77030-
University of Utah - Huntsman Cancer Institute - PPDSSalt Lake CityUtah84112-
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22903-

Find similar trials in Little Rock, AR

By condition
Endometrial cancerGastric cancerOvarian cancer
By specialty
OncologyGynecologic oncologyWomen's healthGI oncology
By research site
University of Arkansas for Medical Sciences· Little Rock, ARUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAStanford Women's Cancer Center· Stanford, CAFlorida Cancer Specialists· Sarasota, FLUniversity of Chicago Medical Center· Chicago, ILJohns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC)· Baltimore, MD

Related Studies