A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Inspirna, Inc.
Study ID
NCT02922764
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • RGX-104 — DRUG
  • Ipilimumab — DRUG
  • Docetaxel — DRUG
  • Pembrolizumab — DRUG
  • Carboplatin — DRUG
  • Pemetrexed — DRUG

Study Details

Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR), as a single agent and in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed.

Key Dates

Start date
Nov 1, 2016
Status verified
Mar 2025
Primary completion
Jan 22, 2025
Completion
Jan 22, 2025

Study Design

Enrollment
146 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Recurrent NSCLC (2nd/3rd Line Lung Cancer). Expansion
    RGX-104 in combination docetaxel RGX104 120 mg BID (5day on/2days off)
  • Experimental: Newly dignosed NSCLC Cohort Expansion
    RGX104 + pembrolizumab + carboplatin/pemetrexed RGX104 120 mg BID (5day on/2days off)
  • Experimental: Recurrent/Relapsed Small Cell Lung Cancer (SCLC) Expansion
    RGX-104 + docetaxel RGX104 120 mg BID (5day on/2days off)
  • Experimental: Recurrent/Relapsed Endometrial Cancer Expansion
    RGX-104 combined with ipilimumab RGX104 120 mg BID (5day on/2days off)

Primary Outcome Measure

Maximum tolerated dose (MTD), or the maximum tested dose at which multiple DLTs are not observed, of RGX-104 as a single agent, and separately, in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed. [ Time Frame: 6 months ]

Locations (21)

FacilityCityStateZIPSite coordinators
Arizona OncologyTucsonArizona85711-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of ColoradoAuroraColorado80045-
Rocky Mountain Cancer CentersDenverColorado80218-
Sarah Cannon Research InstituteDenverColorado80218-
Florida Cancer SpecialistLake MaryFlorida32799-
Comprehensive Hematology OncologySt. PetersburgFlorida33709-
James Graham Brown Cancer CenterLouisvilleKentucky40202-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Maryland OncologyColumbiaMaryland21044-
Regions HospitalSaint PaulMinnesota55101-
Dartmouth Hitchcock MedicalLebanonNew Hampshire03756-
CINJNew BrunswickNew Jersey08901-
Quantum Santa FeSanta FeNew Mexico87505-
Columbia University Medical CenterNew YorkNew York10032-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Oregon Health Sciences UniversityPortlandOregon97239-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
The Sarah Cannon Research InstituteNashvilleTennessee37203-
Virginia Cancer Specialists, PCFairfaxVirginia22031-

Find similar trials in Tucson, AZ

By condition
Endometrial cancerLung cancer
By specialty
OncologyGynecologic oncologyWomen's healthLung oncologyLung disease
By research site
Arizona Oncology· Tucson, AZCedars-Sinai Medical Center· Los Angeles, CAUniversity of Colorado· Aurora, CORocky Mountain Cancer Centers· Denver, COSarah Cannon Research Institute· Denver, COFlorida Cancer Specialist· Lake Mary, FL

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