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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)
Must not have
History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years
Symptomatic brain metastases or leptomeningeal involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two to three years after first dose of repotrectinib dose
Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer before, but it was either skin cancer treated successfully or another type that was completely removed and didn’t need treatment in the last 2 years.
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I have brain metastases or leptomeningeal involvement that causes symptoms.
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I have had serious heart problems recently.
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I have severe lung scarring or disease affecting both lungs.
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I have not had major surgery in the last 4 weeks.
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I have a condition that affects how drugs are absorbed in my body.
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I do not have moderate or severe numbness, tingling, or pain in my hands or feet.
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I do not have any active infections, including HIV.

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

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
377 Total Patients Enrolled
Zai Lab (Shanghai) Co., Ltd.Industry Sponsor
28 Previous Clinical Trials
3,126 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
~164 spots leftby Feb 2028