← Back to Search

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 approximately three years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

My cancer is advanced and tests show specific gene changes.

Select...

I am at least 18 years old, or 20 if required by local laws.

Select...

I can swallow pills without breaking them.

Select...

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:

Select...

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.

Select...

I have brain metastases or leptomeningeal involvement that causes symptoms.

Select...

I have had serious heart problems recently.

Select...

I have severe lung scarring or disease affecting both lungs.

Select...

I have not had major surgery in the last 4 weeks.

Select...

I have a condition that affects how drugs are absorbed in my body.

Select...

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

Select...

I do not have any active infections, including HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two to three years after first dose of repotrectinib dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two to three years after first dose of repotrectinib dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and two to three years after first dose of repotrectinib dose 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

Recommended Phase 2 Dose (RP2D) (Phase 1)

Secondary study objectives

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

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): 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

0 / 12Eligibility criteria met