A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT05307705
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • LOXO-783 — DRUG
    Oral
  • Fulvestrant — DRUG
    Intramuscular
  • Imlunestrant — DRUG
    Oral
  • Abemaciclib — DRUG
    Oral
  • Anastrozole, Exemestane, or Letrozole — DRUG
    Oral
  • Paclitaxel — DRUG
    Intravenous

Study Details

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

Key Dates

First listed
Apr 1, 2022
Start date
May 11, 2022
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1A: LOXO-783 Monotherapy Dose Escalation
    LOXO-783 administered orally
  • Experimental: Phase 1B: Part A
    LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally
  • Experimental: Phase 1B: Part B
    LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally
  • Experimental: Phase 1B: Part C
    LOXO-783 orally in combination with fulvestrant intramuscularly
  • Experimental: Phase 1B: Part D
    LOXO-783 orally in combination with paclitaxel intravenously
  • Experimental: Phase 1B: Part E
    LOXO-783 orally
  • Experimental: Phase 1B: Part F
    Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly

Primary Outcome Measure

Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs) [ Time Frame: During the first 28-day cycle of LOXO-783 treatment ]

Central Contacts

  • There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
    13176154559
    [email protected]

Locations (17)

FacilityCityStateZIPSite coordinators
Mayo Clinic of ScottsdaleScottsdaleArizona85259-
UCLA Medical CenterLos AngelesCalifornia90095-
UCSF Medical Center at Mission BaySan FranciscoCalifornia94158-
Stanford University HospitalStanfordCalifornia94305-
Mayo ClinicJacksonvilleFlorida32224-
Winship Cancer Center Emory UniversityAtlantaGeorgia30322-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55905-0002-
Washington University Medical SchoolSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Wilmot Cancer InstituteRochesterNew York14642-
Tennessee Oncology PLLCNashvilleTennessee37203-
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
UT Southwestern Medical CenterDallasTexas75390-8884-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229-

Find similar trials in Scottsdale, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic of Scottsdale· Scottsdale, AZUCLA Medical Center· Los Angeles, CAUCSF Medical Center at Mission Bay· San Francisco, CAStanford University Hospital· Stanford, CAMayo Clinic· Jacksonville, FLWinship Cancer Center Emory University· Atlanta, GA

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