Study on Repotrectinib for Patients with Advanced Solid Tumors with ALK, ROS1, or NTRK1-3 Gene Changes

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called Repotrectinib (TPX-0005) for patients with advanced solid tumors. These are types of cancer that have spread and are difficult to treat. The study is particularly interested in tumors that have specific changes in their genes, known as ALK, ROS1, or NTRK1-3 rearrangements. These gene changes can affect how cancer grows and responds to treatment.

The purpose of the study is to understand how safe and effective Repotrectinib is for treating these types of tumors. The study will involve taking the medication in the form of a hard capsule by mouth. Participants will be monitored to see how their tumors respond to the treatment and to check for any side effects. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The study will be conducted in multiple phases, starting with a small group of participants to assess safety and then expanding to include more participants to evaluate how well the treatment works. The trial will continue over several years to gather comprehensive data on the treatment’s effectiveness and safety. Participants will be grouped based on their specific type of tumor and previous treatments they have received. This study aims to provide new insights into treating advanced solid tumors with specific genetic changes.

1 joining the study

Upon joining the study, the patient will be assigned to one of six expansion cohorts based on their specific gene rearrangement and previous treatments. These cohorts are designed to evaluate the effectiveness of the medication repotrectinib in patients with advanced solid tumors.

2 medication administration

The patient will receive repotrectinib, which is administered orally in the form of hard capsules. The dosage and frequency will be determined by the study protocol and the patient’s specific cohort assignment.

3 monitoring and assessments

Throughout the study, the patient’s response to the medication will be closely monitored. This includes regular assessments to measure the size of the tumor and any changes in the patient’s condition.

The primary goal is to determine the Objective Response Rate (ORR), which is the proportion of patients whose tumors shrink or disappear after treatment.

4 evaluation of secondary outcomes

Secondary outcomes will also be evaluated, including the Duration of Response (DOR), Time to Response (TTR), and Overall Survival (OS). These measures help to understand the long-term effects of the treatment.

5 completion of the study

The study is expected to continue until February 2028. Upon completion, the data collected will be analyzed to determine the overall effectiveness and safety of repotrectinib in treating advanced solid tumors.

Who Can Join the Study?

The patient must have a confirmed diagnosis of a locally advanced or metastatic solid tumor. This includes tumors that have spread to other parts of the body or are in a stage where surgery or other treatments are not an option.
The tumor must have a specific change in its genes, known as a ROS1 or NTRK1-3 gene fusion. This means that parts of these genes have joined together in a way that is not normal.
The patient must have a test result showing this gene fusion. The test can be done using special methods like next-generation sequencing (NGS), quantitative polymerase chain reaction (qPCR), or fluorescence in situ hybridization (FISH). These are advanced tests that look at the genes in detail.
The patient must have at least one tumor that can be measured using a specific method called RECIST. This is a way to measure how big the tumor is and if it changes over time.
The patient will be placed into one of six groups based on their previous treatments and the type of gene fusion they have:

Group 1: Patients with ROS1+ NSCLC who have not had a specific type of treatment called ROS1 TKI before. They can have had one previous treatment with chemotherapy or immunotherapy.
Group 2: Patients with ROS1+ NSCLC who have had one ROS1 TKI and one chemotherapy treatment. They must have had a specific type of chemotherapy called platinum-based chemotherapy.
Group 3: Patients with ROS1+ NSCLC who have had two ROS1 TKI treatments but no chemotherapy or immunotherapy.
Group 4: Patients with ROS1+ NSCLC who have had one ROS1 TKI treatment but no chemotherapy or immunotherapy.
Group 5: Patients with NTRK+ solid tumors who have not had a specific type of treatment called TRK TKI before. They can have had any number of chemotherapy or immunotherapy treatments. Patients with NSCLC are not allowed in this group.
Group 6: Patients with NTRK+ solid tumors who have had one or two TRK TKI treatments. They can have had any number of chemotherapy or immunotherapy treatments. Patients with NSCLC are not allowed in this group.

The study is open to male patients only.

Who Cannot Join the Study?

Patients with medical conditions other than advanced solid tumors cannot participate. Advanced solid tumors are a type of cancer that has spread to other parts of the body.
Patients who do not have a specific gene change called ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement are excluded. These are specific changes in the genes that can affect how cancer grows.
Only male patients are eligible, so female patients cannot participate.
Patients who are considered part of a vulnerable population are excluded. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Koranyi National Institute For Pulmonology	Budapest	Hungary
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Semmelweis University	Budapest	Hungary
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Roskilde University	Roskilde	Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ityvwq Igaurxfa Fbywiirrchige Ojkqqdgaagz	Rome	Italy
Uapnnbnhgtsa Mornwru Ccqmuwu Gzoaijayw	Groningen	The Netherlands
Nqhojnvl Icplhinu Onhtkfisb Ixo Mwcmz Sfwswnrqcvnqpqnaxnnaitmjpltx Iaposujb Buhspfag	Cracow	Poland
Ufcjfnbehpspyw Cczgfvs Kkxwtrjrj	Gdansk	Poland
Hrljduvg Vrko dwdvtozw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	28.06.2019
Denmark	Not recruiting	28.06.2019
France	Recruiting	28.06.2019
Germany	Recruiting	28.06.2019
Hungary	Not recruiting	28.06.2019
Italy	Recruiting	28.06.2019
Poland	Recruiting	28.06.2019
Spain	Recruiting	28.06.2019
The Netherlands	Recruiting	28.06.2019

Trial locations

Investigated drugs:

Repotrectinib

Repotrectinib is a medication being studied for its potential to treat advanced solid tumors. These tumors have specific genetic changes known as ALK, ROS1, or NTRK1-3 rearrangements. The study aims to evaluate how safe and tolerable this medication is for patients, as well as how it behaves in the body and its ability to fight tumors.

Advanced Solid Tumors – Advanced solid tumors are a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to a more severe stage. These tumors are characterized by their ability to grow uncontrollably and invade nearby tissues. As they advance, they may spread to other parts of the body, a process known as metastasis. The progression of these tumors can vary depending on the type of cancer and its location. They often lead to the formation of masses or lumps that can be detected through imaging or physical examination. The behavior and growth rate of advanced solid tumors can differ significantly, influencing the symptoms experienced by the patient.

Trial ID:

2024-512606-25-00

Protocol code:

TPX-0005-01

NCT ID:

NCT03093116

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on Repotrectinib for Patients with Advanced Solid Tumors with ALK, ROS1, or NTRK1-3 Gene Changes

What is this study about?

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