Study on the Safety and Effects of RP-1664 for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying advanced solid tumors, which are types of cancer that have spread beyond their original location and are not responding to standard treatments. The trial will test a new treatment called RP-1664, which is an inhibitor of Polo-Like Kinase 4 (PLK4). This treatment is taken orally in the form of a hard capsule. The purpose of the study is to assess the safety and tolerability of RP-1664 in participants with advanced solid tumors and to determine a suitable dose and schedule for its use.

Participants in the study will receive the treatment and be monitored for any side effects or changes in their condition. The study will also look at how the body processes the drug, including how long it stays in the body and how it is eliminated. This information will help researchers understand the drug’s effects and how it might benefit patients with advanced solid tumors.

The trial will continue until 2027, with the aim of gathering enough data to evaluate the treatment’s effectiveness and safety. Participants will be closely observed throughout the study to ensure their well-being and to collect valuable information that could lead to new treatment options for those with advanced solid tumors.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

A negative pregnancy test is required for women of childbearing potential. Male participants with female partners must follow a contraception method.

2 baseline evaluation

A baseline evaluation is performed to measure the current state of the disease. This involves providing tumor tissue samples and undergoing imaging tests to assess tumor size.

3 medication administration

The medication RP-1664 sulfate is administered orally in the form of hard capsules. The dosage and schedule are determined based on individual tolerance and clinical activity.

Participants must be able to swallow and retain the capsules.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effects of the medication. This includes checking for any adverse events and measuring plasma concentrations of RP-1664.

Participants may be required to consume a high-fat meal and fast for 12 hours if involved in the food effect portion of the trial.

5 evaluation of response

The response to the treatment is evaluated using imaging tests to measure changes in tumor size. The objective response rate and clinical benefit rate are assessed.

Progression-free survival is also monitored to determine the duration of time the disease does not worsen.

6 completion of trial

The trial is estimated to end by May 2027. Participants will continue to be monitored until the trial’s conclusion or until they are no longer benefiting from the treatment.

Who Can Join the Study?

Participants must provide written informed consent or assent, which means they agree to join the study after understanding what it involves. If a participant has trouble making decisions, a caregiver or legal representative must be present.
Participants must be at least 18 years old when they sign the consent form.
Participants must be able to swallow and keep oral medications in their stomach.
Participants should have a life expectancy of at least 4 months after starting the treatment, as judged by the study doctor.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or a Lansky performance status of at least 60%. These are scales used to measure how well a person can perform daily activities.
Participants must have a locally advanced or metastatic solid tumor that has either worsened or not responded to available treatments, and for which no standard or curative treatment exists.
Participants must have a measurable disease according to specific medical guidelines called RECIST v1.1 or INRC.
Participants must provide a sample of their tumor tissue. If an old sample is not available, a new biopsy must be done before joining the study.
All participants’ tumors must show evidence of a specific genetic change called gain or amplification of TRIM37, confirmed by a certified laboratory.
Participants must have acceptable organ function during the screening process.
Participants must have acceptable blood function during the screening process.
Women who can have children must have a negative pregnancy test at screening.
Male participants with female partners who can have children must use a method of birth control.
For those in the part of the trial studying the effect of food, participants must be able to eat a high-fat meal and fast for 12 hours.

Who Cannot Join the Study?

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	30.08.2024

Trial locations

Investigated drugs:

Rp-1664 Sulfate

RP-1664 is an investigational medication being studied for its safety and how it behaves in the body when given to participants with advanced solid tumors. The trial aims to find a dose and schedule that is both safe and effective for patients.

Investigated diseases:

Neoplasm

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, or spread to other parts of the body through the bloodstream or lymphatic system. The progression of these tumors can lead to symptoms such as pain, swelling, or dysfunction of the affected organ. The growth and spread of the tumors can vary depending on the type of cancer and its location. Understanding the behavior of these tumors is crucial for determining appropriate management strategies.

Trial ID:

2024-511259-16-00

Protocol code:

RP-1664-01

NCT ID:

NCT06232408

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study on the Safety and Effects of RP-1664 for Patients with Advanced Solid Tumors

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