Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
TPX-0046-01 (primary)
NCI-2019-08596
Summary
A phase 1/2, first-in-human, open-label study to determine the safety, tolerability, PK, and
preliminary efficacy of the novel RET/SRC inhibitor TPX-0046 in adult subjects with advanced
or metastatic solid tumors harboring RET mutations or alterations. The study consists of
three portions: 1) Phase 1 Dose Escalation and Food Effect Sub-study, and 2) Phase 1 dose
expansion and 3) Phase 2 efficacy evaluation.
Objectives
Phase 1 Dose Escalation and Dose Expansion: To evaluate the overall safety profile,
characterize the PK profiles and assess the preliminary efficacy of TPX-0046 in adults
subjects with advanced solid tumors harboring oncogenic RET fusions or mutations.
Food Effect Sub-Study: To determine the effect of food on PK of TPX-0046 in adult subjects
with advanced or metastatic solid tumors harboring oncogenic RET fusions or mutations.
Phase 2 Efficacy Evaluation: To determine the overall safety and anti-tumor efficacy of
TPX-0046 in defined cohorts of subjects with advanced/metastatic solid tumors harboring
oncogenic RET fusions or mutations.
Eligibility
- Age = 18 (or age = 20 as required by local regulation).
- Histological or cytological confirmation of advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations, who either have disease progression on, or are intolerant to standard therapy; OR are ineligible for standard therapy or for whom no standard therapy exists; OR are unlikely to tolerate or derive clinical benefit from standard therapy in the opinion of the Investigator OR have declined standard therapy.
- ECOG performance status = 1.
- Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
- Subjects with asymptomatic primary CNS tumors or brain metastases are eligible for the study if they meet protocol specified criteria.
- Adequate organ function.
- Life expectancy = 12 weeks.
Treatment Sites in Georgia
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