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Tyrosine Kinase Inhibitor

Repotrectinib for Solid Tumors (TRIDENT-1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Turning Point Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests
Age ≥18 (or age ≥ 20 as required by local regulation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two to three years after first dose of repotrectinib dose
Awards & highlights

TRIDENT-1 Trial Summary

This trial will study the side effects and best dose of repotrectinib in adults with advanced solid tumors that have a certain gene rearrangement. It will also study how repotrectinib affects the body's metabolism of midazolam.

Who is the study for?
Adults with advanced solid tumors that have specific gene rearrangements (ALK, ROS1, NTRK1-3) can join this trial. They should have at least one measurable tumor and a life expectancy of over 3 months. Prior cancer treatments are okay if side effects are minimal now. People with certain heart conditions, active infections, significant lung disease or recent major surgery cannot participate.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of an oral drug called repotrectinib in two phases: first to find the safest dose and then to see how well it works against tumors. It also looks into how repotrectinib affects another drug's breakdown in the body.See study design
What are the potential side effects?
Possible side effects include reactions related to liver function, blood cell counts, potential nerve damage (neuropathy), and risks associated with heart rhythm changes. Specific side effect details will be monitored throughout the trial.

TRIDENT-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced and tests show specific gene changes.
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I am at least 18 years old, or 20 if required by local laws.
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I can swallow pills without breaking them.
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I am fully active or can carry out light work.

TRIDENT-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately three years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLTs) (Phase 1)
Overall Response Rate (ORR) Phase 2
Recommended Phase 2 Dose (RP2D) (Phase 1)
Secondary outcome measures
Area under the plasma concentration time curve (AUC) of midazolam(TPX-0005) (Phase 1)
Area under the plasma concentration time curve (AUC) of repotrectinib (TPX-0005) (Phase 1)
Area under the plasma concentration time curve (AUC) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1)
+10 more

TRIDENT-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: Repotrectinib (TPX-0005)Experimental Treatment1 Intervention
Phase 1 Oral repotrectinib (TPX-0005): Phase 1a dose escalation, Phase 1b food-effect sub-study, and Phase 1c dose escalation with food, and Midazolam drug-drug interaction sub-study. Phase 2 Oral repotrectinib (TPX-0005): 6 distinct expansion cohorts EXP-1: ROS1 TKI-naïve ROS1+ NSCLC EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) EXP-5: TRK TKI-naïve NTRK+ solid tumors EXP-6: TRK TKI-pretreated NTRK+ solid tumors

Find a Location

Who is running the clinical trial?

Turning Point Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
402 Total Patients Enrolled
Zai Lab (Shanghai) Co., Ltd.Industry Sponsor
28 Previous Clinical Trials
3,181 Total Patients Enrolled
Shanna Stopatschinskaja, M.D.Study DirectorTurning Point Therapeutics, Inc.

Media Library

Repotrectinib (TPX-0005) (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03093116 — Phase 1 & 2
Solid Tumors Research Study Groups: Repotrectinib (TPX-0005)
Solid Tumors Clinical Trial 2023: Repotrectinib (TPX-0005) Highlights & Side Effects. Trial Name: NCT03093116 — Phase 1 & 2
Repotrectinib (TPX-0005) (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03093116 — Phase 1 & 2
Solid Tumors Patient Testimony for trial: Trial Name: NCT03093116 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues is this clinical investigation being administered in?

"Presently, this trial is running out of 72 sites that span from Edmonton to Philadelphia and even Oxnard. To ease the burden of participation, it would be wise to select a clinic near you when registering."

Answered by AI

What are the key targets of this investigation?

"The preeminent metric for this trial, tracked within 28 days of the initial repotrectinib dose, is to determine an ideal Recommended Phase 2 Dose (RP2D). Secondary objectives include assessing Maximum plasma concentration (CMAX) under varying food intake conditions(TPX-0005), determining Intracranial objective response rate in patients receiving repotrectinib treatment, and measuring Duration of response (DOR) associated with using this drug."

Answered by AI

Are there still opportunities to participate in this clinical experiment?

"According to the records on clinicaltrials.gov, enrollment for this trial is still ongoing since its original posting date of February 27th 2017 and was most recently amended on November 29th 2022."

Answered by AI

What is the recruitment size for this clinical trial?

"The sponsor, Turning Point Therapeutics Inc., must recruit 500 suitable patients in order to execute the study. These individuals will be recruited from two locations: Cross Cancer Institute PHASE 2 (Edmonton, Alberta) and Fox Chase Cancer Centre PHASE 2 (Philadelphia, Pennsylvania)."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
UT Southwestern Medical Center PHASE 2
Memorial Healthcare System PHASE 2
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I believe in trials and have feat.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Memorial Healthcare System PHASE 2: < 48 hours
~179 spots leftby Feb 2028