FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT05614739
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Neoplasm Metastasis
  • Ureteral Neoplasms
  • Urinary Bladder Neoplasms

Eligibility Criteria

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

Interventions

  • LOXO-435 — DRUG
    Oral
  • Pembrolizumab — DRUG
    IV
  • enfortumab vedotin — DRUG
    IV

Study Details

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.

Key Dates

Start date
Jan 12, 2023
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose Escalation
    LOXO-435 administered orally
  • Experimental: Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose Optimization
    LOXO-435 administered orally
  • Experimental: Phase 1b: Cohort B1, B2, B4, and C1 LOXO-435 Monotherapy Dose Expansion
    LOXO-435 administered orally
  • Experimental: Phase 1b: Cohort B3 LOXO-435 Plus Pembrolizumab
    LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV)
  • Experimental: Phase 1b: Cohort B5 LOXO-435 Plus Pembrolizumab Plus Enfortumab Vedotin
    LOXO-435 administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV

Primary Outcome Measure

Phase 1a: To determine the recommended dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Minimum of the first 21-day cycle of LOXO-435 treatment ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (41)

FacilityCityStateZIPSite coordinators
University of Arizona - Cancer CenterTucsonArizona85719-
City of HopeDuarteCalifornia91010-
University of California, Los Angeles (UCLA) - Division of Hematology-OncologyLos AngelesCalifornia90095-
University of California - IrvineOrangeCalifornia92868-
University of California (UC) Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Stanford Medicine Cancer CenterStanfordCalifornia94305-
Advent HealthOrlandoFlorida32804-
Emory University HospitalAtlantaGeorgia30322-
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637-
Indiana University (IU) Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Johns Hopkins Kimmel Cancer CenterBaltimoreMaryland21231-2410-
Massachusetts General HospitalBostonMassachusetts02114-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Washington University in St. LouisSt LouisMissouri63108-
Columbia UniversityNew YorkNew York10032-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
New York University (NYU)New YorkNew York10016-
Weill Cornell MedicineNew YorkNew York10021-
University of Rochester - Wilmot Cancer InstituteRochesterNew York14642-
Montefiore Medical CenterThe BronxNew York10467-
University of North Carolina (UNC) - Chapel HillChapel HillNorth Carolina27599-
University of Cincinnati Medical Center (UCMC)CincinnatiOhio45267-
The Ohio State University (OSU)ColumbusOhio43210-
University of Oklahoma - Health Sciences CenterOklahoma CityOklahoma73104-
Penn Medicine Lancaster General Hospital - Ann B. Barshinger Cancer InstituteLancasterPennsylvania17601-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Sarah Cannon and HCA Research InstituteNashvilleTennessee37203-
Tennessee OncologyNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37212-
Texas Oncology, P.ADallasTexas75251-
University of Texas SouthwesternDallasTexas75244-
MD Anderson Cancer CenterHoustonTexas77030-
University of UtahSalt Lake CityUtah84132-
University of Vermont Medical CenterBurlingtonVermont05401-

Find similar trials in Tucson, AZ

By research site
University of Arizona - Cancer Center· Tucson, AZCity of Hope· Duarte, CAUniversity of California, Los Angeles (UCLA) - Division of Hematology-Oncology· Los Angeles, CAUniversity of California - Irvine· Orange, CAUniversity of California (UC) Davis Comprehensive Cancer Center· Sacramento, CAStanford Medicine Cancer Center· Stanford, CA

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