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Terminated Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04161391

Public ClinicalTrials.gov record NCT04161391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04161391
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
41 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 6, 2019 (Actual)
Primary completion
May 22, 2023 (Actual)
Completion
May 22, 2023 (Actual)
Last update posted
Jun 13, 2024

2019 – 2023

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Local Institution - 2129 La Jolla California 92093 —
Local Institution - 2128 Orange California 92868 —
Local Institution - 2122 Aurora Colorado 80045 —
SCRI - HealthOne Denver Denver Colorado 80218 —
Local Institution - 2126 Washington D.C. District of Columbia 20007 —
Mayo Clinic - Jacksonville Jacksonville Florida 32224 —
Local Institution - 2130 Tampa Florida 33612-9416 —
Local Institution - 2127 Atlanta Georgia 30322 —
University of Chicago Medicine Chicago Illinois 60637 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Local Institution - 2124 Ann Arbor Michigan 48109-5000 —
Local Institution - 2131 Detroit Michigan 48201 —
Mayo Clinic - Arizona Rochester Minnesota 55905 —
Mayo Clinic - Rochester Rochester Minnesota 55905 —
Memorial Sloan Kettering Cancer Center New York New York 10021 —
Local Institution - 2137 Philadelphia Pennsylvania 19111 —
Local Institution - 2120 Houston Texas 77030-3721 —
Baylor College of Medicine - Baylor Heart Clinic Houston Texas 77030 —
Local Institution - 2135 Fairfax Virginia 22031 —
Local Institution - 2132 Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04161391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 13, 2024 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04161391 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →