RET-positive Ongoing Clinical Trials

Clinical trials looking at possible next-generation RET inhibitors in all solid tumors with RET gene abnormalities:

These clinical trials are looking at the safety and efficacy (in humans) of novel agents developed to overcome resistance mechanisms seen in patients who have progressed on the ‘first generation’ RET-targeting tyrosine kinase inhibitors (TKIs) Selpercatinib (Retevmo) and Pralsetinib (Gavreto).

ClinicalTrials.gov ID Title Phase Locations Sponsor Date Opened Contact
NCT05241834 Study of LOXO-260, in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment I/II Boston, Massachusetts, Cleveland, Ohio, Nashville, Tennessee Loxo Oncology March-22 clinicaltrials@loxooncology.com
NCT04683250 Study of the Selective RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET gene abnormalities I/II Grand Rapids, Michigan Nashville, Tennessee Helsinn Healthcare Dec-20 nehal.lakhani@startmidwest.com mjohnson@tnonc.com
NCT04161391 Study of TPX-0046, a RET/SRC Inhibitor in Adult Subjects with Advanced Solid Tumors Harboring RET Fusions or Mutations I/II Irvine and San Diego California, Aurora and Denver Colorado, Washington DC, Tampa Florida, Atlanta Georgia, Ann Arbor and Detroit Michigan, Boston Massachusetts, New York New York, Seattle Washington, Houston Texas, Seoul Korea Turning Point Therapeutics Nov-19 clinical@tptherapeutics.com
NCT05443126 A Study of EP0031-101 in Patients With Advanced RET-altered Malignancies I/II

Los Angeles California, Cleveland Ohio, Portland Oregon, Houston Texas

 Ellipses Pharma Jul-22 Liz@ellipses.life
NCT05653869 A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions I

Shanghai China

 Applied Pharmaceutical Science, Inc. Dec-22 liuxueying@apspharm.com, zhongjun@apspharm.com

Clinical trials looking at first-generation RET inhibitors in all RET-positive solid tumors:

ClinicalTrials.gov ID Title Phase Locations Sponsor Date Opened Contact
NCT03037385 Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors (ARROW) I/II 79 locations worldwide Blueprint Medicines Corporation Mar-17 studydirector@blueprintmedicines.com
NCT03157128 Phase 1/2 Study of LOXO-292 in Patients with Advanced Solid Tumors, RET Fusion-positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) I/II 84 locations world wide Loxo Oncology May-17 clinicaltrials@loxooncology.com
NCT03157128 Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study II 153 locations world wide Hoffmann-La Roche October-20 Global-Roche-Genentech-Trials@gene.com

Clinical trials comparing first-generation RET inhibitors to standard-of-care chemotherapy in RET Fusion-positive NSCLC:

ClinicalTrials.gov ID Title Phase Locations Sponsor Date Opened Contact
NCT04194944 A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (LIBRETTO-431) III 216 Locations world wide Eli Lilly Feb-20 ClinicalTrials.gov@lilly.com
NCT04222972 AcceleRET Lung Study of Pralsetinib for 1L RET Fusionpositive, Metastatic NSCLC III 58 Locations world wide Blueprint Medicines Corporation Jan-20 medinfo@blueprintmedicines.com

Clinical trials looking at first-generation RET inhibitors for RET-altered Thyroid Cancers:

ClinicalTrials.gov identifier Number Title Phase Locations Sponsor Date Opened Contact
NCT04211337 A Study of Selpercatinib (LY3527723) in Participants with RET-Mutant Thyroid Cancer (LIBRETTO-531) III 156 study locations worldwide Eli Lilly Dec-19 ClinicalTrials.gov@lilly.com
NCT04759911 Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer II MD Anderson MD Anderson Not yet recruiting mzafereo@mdanderson.org
NCT04760288 A study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer III Not yet recruiting Hoffmann-La Roche Not yet recruiting global-roche-genentech-trials@gene.com