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  • A Phase 1/2 Study of TPX-0046, a Novel Oral RET/SRC Inhibitor in Adult Subjects with Advanced/Metastatic Solid Tumors Harboring Oncogenic RET Fusions or Mutations

    Cancer Categories
    • Head and Neck,Lung
    Karmanos Trial ID
    • 2020-032
    NCT ID
    • NCT04161391
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator

    Objective:

    Primary Objectives Phase 1:
    • Evaluate the safety and tolerability of TPX-0046 at selected doses in subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations
    • Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0046 in subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations

    Primary Objectives Phase 2:
    • Determine the preliminary efficacy by the objective response rate (ORR) in defined cohorts of subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations

    Secondary Objectives Phase 1:
    • Evaluate the overall safety profile of TPX-0046 in subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations
    • Characterize the pharmacokinetic (PK) properties of TPX-0046 in adult subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations
    • Assess the preliminary efficacy of TPX-0046 in adult subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations

    Secondary Objectives Phase 2:
    • Characterize the efficacy of TPX-0046 in defined cohorts of subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations in terms of DOR, PFS and overall survival (OS)
    • Characterize the intracranial efficacy of TPX-0046 in defined cohorts of subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations with central nervous system (CNS) metastases
    • Evaluate the overall safety profile of TPX-0046 in defined cohorts of subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations
    • Confirm PK profiles of TPX-0046 at the RP2D in defined cohorts of subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations
    • Estimate the effect of TPX-0046 on patient reported outcomes, global health status/Quality of Life (QOL)
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266