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NCT03093116 · ClinicalTrials.gov registry record · Phase 1

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

A Phase 1 study of Metastatic Solid Tumors and Locally Advanced Solid Tumors, sponsored by Turning Point Therapeutics.

Compiled by PlainTrial · August 8, 2026

Recruiting
Registry status: Phase 1
Development phase: 500
Enrollment target: 20
Study locations

NCT03093116: Recruiting Phase 1 study of Metastatic Solid Tumors and Locally Advanced Solid Tumors, sponsored by Turning Point Therapeutics.

NCT03093116 is a Phase 1 study of Metastatic Solid Tumors and Locally Advanced Solid Tumors that is actively recruiting participants, run by Turning Point Therapeutics. The registered enrollment target is 500 participants, above the 181-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (176% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03093116, a Phase 1 study of Metastatic Solid Tumors and Locally Advanced Solid Tumors, is actively recruiting participants, sponsored by Turning Point Therapeutics.

RECRUITING
Registry status: Phase 1
Development phase: 500 participants
Enrollment target: 20
Study locations

Study Summary

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Primary Outcome

Define the dose limiting toxicities (DLTs) (Phase 1)

Conditions Studied

Metastatic Solid Tumors Locally Advanced Solid Tumors

Interventions

DRUG Oral repotrectinib (TPX-0005)

Study Locations (20)

California

Local Institution - 2129 - Duarte
Local Institution - 2120 - Glendale
Local Institution - 2136 - La Jolla
Local Institution - 2114 - La Jolla
Local Institution - 2121 - Long Beach
Local Institution - 2101 - Orange
University of California Irvine Medical Center - Orange
Local Institution - 2126 - Santa Rosa

Colorado

Local Institution - 1003 - Aurora
Local Institution - 2103 - Aurora

District of Columbia

Local Institution - 2106 - Washington D.C.
Local Institution - 2110 - Washington D.C.

Florida

Local Institution - 2128 - Hollywood
Local Institution - 2113 - Tampa

Georgia

Local Institution - 2139 - Athens
Local Institution - 2134 - Columbus

Illinois

Local Institution - 2125 - Chicago
Local Institution - 2142 - Peoria

Louisiana

Local Institution - 2116 - New Orleans

Maryland

Local Institution - 2133 - Baltimore

Trial Details

Field	Value
Enrollment Target	500 participants
Start Date	2017-03-07
Est. Completion	2028-02-29
Phase	Phase 1

Turning Point Therapeutics

7 total trials

What NCT03093116 shows while recruiting

NCT03093116 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (176% higher).

The record links to 2 conditions, with Metastatic Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Oral repotrectinib (TPX-0005) is the first listed.

NCT03093116 names 20 study sites across 8 states, led by California, Colorado, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT03093116 about?

NCT03093116 is a clinical study titled "A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements". Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2...

What is the current status of trial NCT03093116?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 500 participants. The study started on 2017-03-07. Estimated completion is 2028-02-29.

What conditions does trial NCT03093116 study?

This clinical trial studies the following conditions: Metastatic Solid Tumors, Locally Advanced Solid Tumors.

What interventions are being tested in trial NCT03093116?

The interventions under investigation include: Oral repotrectinib (TPX-0005) (DRUG).

Who is sponsoring clinical trial NCT03093116?

This trial is sponsored by Turning Point Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03093116 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03093116's enrollment target sits among peer trials

500 2nd of 20 the highest of 20 other Metastatic Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03093116, the US trial registry maintained by the National Library of Medicine. NCT03093116 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.