RecruitingPHASE1, PHASE2INTERVENTIONAL

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

This research study is investigating a new oral medicine called repotrectinib (also known as TPX-0005) for people with advanced solid cancers. These are cancers that have spread or are difficult to treat with standard methods. The study is particularly looking at cancers that have specific genetic changes called ALK, ROS1, or NTRK rearrangements. It has two main parts: Phase 1 is about finding the right dose of the new drug, how safe it is, and what side effects it might cause. Phase 2 then looks at how effective repotrectinib is in making tumours shrink or stopping them from growing in different types of cancer with these gene changes, especially ROS1 and NTRK. Researchers will also check how long the positive effects last and how quality of life is affected.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Turning Point Therapeutics, Inc.

Enrolment target

500

Start

07 Mar 2017

Estimated completion

29 Feb 2028

Locally Advanced Solid Tumors Metastatic Solid Tumors

What is this study about?

This clinical trial is designed to investigate a new medication called repotrectinib (also known as TPX-0005). Researchers are hoping this new drug could be a helpful treatment option for people who have advanced solid cancers. 'Advanced' means the cancer has either spread to other parts of the body (metastatic) or is in a later stage locally.

The study is focusing on cancers that have a specific type of genetic change, often called a gene 'rearrangement' or 'fusion'. These changes involve genes named ALK, ROS1, or NTRK1-3. These gene changes can sometimes make cancer cells grow and spread. Medicines that target these specific changes are often called 'targeted therapies' and can sometimes be very effective because they specifically attack the cancer cells while leaving healthy cells alone as much as possible.

The study has two main parts, called phases. Phase 1 is about finding the best dose of repotrectinib that can be given safely without causing too many side effects. It also helps researchers understand how the medicine works in the body and if there are any early benefits. Phase 2 then takes that information and looks more closely at how well the drug works in shrinking tumours or stopping them from growing in different groups of people whose cancers have these specific ROS1 or NTRK gene changes. They will also look at how long any positive effects last and how the treatment affects a person's overall health and wellbeing.

Key takeaways

This study is testing a new oral drug called repotrectinib for advanced solid cancers.
It focuses on cancers with specific genetic changes (ALK, ROS1, or NTRK).
Phase 1 finds the safest dose, and Phase 2 checks how well it works.
Participants take capsules and have regular check-ups and scans.
This is an experimental treatment, and its benefits are not guaranteed.

Who may be eligible?

To be considered for this study, you would generally need to have an advanced solid cancer that has specific genetic changes involving the ALK, ROS1, or NTRK genes. Doctors will use special tests to check for these changes. Your overall health and how well you can carry out daily activities will also be important, and you'll need to be well enough to take the study medication by mouth.

There are also specific medical requirements your doctor will check, such as your blood test results and how certain organs like your liver and kidneys are working. You and your doctor will need to review all the detailed eligibility criteria to see if this study could be a suitable option for you. The study includes people from 12 years of age and older.

For Phase 2, the focus is specifically on cancers with ROS1 or NTRK gene changes. There are several different groups within Phase 2 depending on whether you've had previous treatments for your cancer, such as targeted therapies or chemotherapy, and how those treatments worked.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have an advanced solid cancer diagnosis?
Do tests show my cancer has an ALK, ROS1, or NTRK gene change?
Am I generally well enough to participate in a clinical study?
Am I able to swallow capsules whole?
Have I discussed my previous cancer treatments with my doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study drug, repotrectinib, as a capsule to take by mouth. The study involves regular visits to the hospital or clinic for assessments. These assessments will include blood tests, scans (like CT or MRI) to check your cancer, and check-ups with the doctor to see how you are feeling and if you have any side effects.

How often you visit and for how long depends on which part of the study you are in and how you respond to the treatment. There will be initial frequent visits, which may become less frequent over time. The total duration of your participation will depend on how your cancer responds to the treatment and your overall health, but it could last for many months or even longer if the treatment is helping.

Potential risks and benefits

Like all medicines, repotrectinib might have side effects, which the study team will monitor closely. These will be explained to you in detail. There is no guarantee that repotrectinib will help your cancer, but participating could provide valuable information that helps others in the future. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (165)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 2129
Verified postcode
Duarte, United States· Completed
Local Institution - 2120
Verified postcode
Glendale, United States· Completed
Local Institution - 2136
Verified postcode
La Jolla, United States· Withdrawn
Local Institution - 2114
Verified postcode
La Jolla, United States· Completed
Local Institution - 2121
Verified postcode
Long Beach, United States· Completed
Local Institution - 1001
Verified postcode
Orange, United States· Completed
Local Institution - 2101
Verified postcode
Orange, United States· Completed
St Joseph Heritage Healthcare
Verified postcode
Santa Rosa, United States· Recruiting
Local Institution - 1003
Verified postcode
Aurora, United States· Completed
Local Institution - 2103
Verified postcode
Aurora, United States· Completed
Local Institution - 2106
Verified postcode
Washington D.C., United States· Completed
Local Institution - 2110
Verified postcode
Washington D.C., United States· Completed

Common questions

What is repotrectinib and how is it given?

Repotrectinib is a new experimental drug in the form of a capsule that you take by mouth.

What kind of cancers is this study for?

It's for advanced solid cancers that have specific genetic changes in the ALK, ROS1, or NTRK genes.

What does 'gene rearrangement' mean?

It's a change in your cancer's genetic material that can make the cancer grow. This drug aims to target that specific change.

Will I know if the drug is working?

The study team will use scans and tests to check how your cancer responds to the treatment.

Can I stop participating in the study if I want to?

Yes, you can choose to stop participating at any time without it affecting your medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.