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Tyrosine Kinase Inhibitor

Repotrectinib for Solid Tumors in Young Patients

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

Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve

Age <12 years for Phase 1 and age 12-25 years for Phase 2

Must not have

Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers

Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately three years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for safety and effectiveness in treating pediatric and young adult cancer patients.

Who is the study for?

This trial is for young individuals with advanced or metastatic cancers like brain tumors, solid tumors, and lymphoma that have specific genetic changes (ALK, ROS1, NTRK1-3). They should have had prior treatments but be in stable condition. It's not for those with certain heart risks, active infections, severe neuropathy or gastrointestinal conditions affecting drug absorption.

What is being tested?

The study tests different doses of an oral drug called repotrectinib to find the safest and most effective amount for children and young adults. Phase 1 focuses on safety and finding the right dose; Phase 2 checks how well it works against their cancer.

What are the potential side effects?

While specific side effects aren't listed here, common ones from drugs like repotrectinib could include fatigue, nausea, diarrhea, liver issues and potential heart problems. The exact side effects will be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced solid tumor is NTRK fusion positive and I haven't taken TRK inhibitors.

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I am under 12 for Phase 1 or between 12-25 for Phase 2.

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My cancer has a confirmed ALK, ROS1, or NTRK1-3 genetic change.

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My cancer can be measured by specific medical criteria.

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All side effects from my previous cancer treatments, except for hair loss, are mild or gone.

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I can do most activities but need help with some, regardless of my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking or might need strong medication that affects liver enzymes.

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I have a condition like Crohn's disease that affects how my body absorbs drugs.

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I have a condition or take medication that can affect my heart's rhythm.

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I do not have any active infections, including HIV.

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I do not have moderate or severe numbness, tingling, or pain in my hands or feet.

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My neuroblastoma is only in my bone marrow and can be checked with a bone marrow test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately three years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicities (DLTs) (Phase 1)

Overall Response Rate (ORR) (Phase 2)

Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)

Secondary study objectives

Area under the concentration versus time curve of repotrectinib in plasma (AUC)

Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2)

Clinical Benefit Rate (CBR) (Phase 1 and Phase 2)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Repotrectinib (TPX-0005)Experimental Treatment1 Intervention

Phase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ROS1 gene fusions or other ROS1 aberrations

0 / 12Eligibility criteria met