Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations

Active:	No
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT04161391
Trial Phases:	Phase I Phase II	Protocol IDs:	TPX-0046-01 (primary) NCI-2019-08596
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Turning Point Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04161391

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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