Study on the Safety of RP-6306 Alone or with RP-3500 or Debio 0123 for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying the safety and effects of a new treatment for patients with advanced solid tumors. These are types of cancer that have spread beyond their original location and are difficult to treat. The study involves a medication called RP-6306, which is being tested alone and in combination with other drugs, RP-3500 and Debio 0123. RP-6306 is an anti-tumor agent, while RP-3500 is an ATR inhibitor, a type of drug that targets specific proteins in cancer cells. Debio 0123 is a highly selective inhibitor of the WEE1 kinase, which is another protein involved in cancer cell growth.

The purpose of the study is to assess how safe and tolerable these treatments are for patients with certain genetic changes in their tumors, such as CCNE1 amplification or mutations in genes like FBXW7. The study will also determine the best dose and schedule for these medications. Patients will take the medications orally, in the form of capsules or tablets. The study will monitor the patients’ health and any side effects they experience, as well as how the cancer responds to the treatment.

Throughout the study, patients will undergo regular check-ups and tests to track their progress. The study aims to find the most effective and safe way to use these medications to help treat advanced solid tumors. The trial is expected to continue until 2027, with the goal of improving treatment options for patients with these challenging types of cancer.

1 joining the study

Upon joining the study, the patient will begin by taking part in a Phase 1 trial. This trial is designed to assess the safety and tolerability of the medication RP-6306, either alone or in combination with other medications such as RP-3500 or Debio 0123.

The patient will be required to provide written informed consent before any study-specific procedures are performed.

2 medication administration

The patient will receive the medication in the form of hard capsules or tablets, which are to be taken orally.

The specific medication regimen will depend on the module of the study the patient is enrolled in. For example, RP-6306 may be administered alone or in combination with RP-3500 or Debio 0123.

3 monitoring and assessments

Throughout the study, the patient will undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes laboratory assessments, vital signs, and electrocardiograms (ECGs).

The patient will also be monitored for any treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs).

4 dose determination

The study aims to determine the maximum tolerated dose (MTD) of RP-6306, both as a monotherapy and in combination with other medications.

The recommended Phase 2 dose (RP2D) and preferred schedule will be established based on the findings from this phase.

5 evaluation of treatment effects

The study will evaluate the preliminary anti-tumor activity of the medications. This includes measuring changes in tumor size and assessing the overall response rate (ORR) and duration of response (DOR).

The patient may also undergo biomarker assessments and circulating tumor DNA (ctDNA) analysis to further understand the treatment’s effects.

6 completion of the study

The estimated end date for the study is April 27, 2027. The patient will continue to be monitored until the study’s completion or until they are no longer able to participate.

Upon completion, the patient will receive a final assessment to evaluate their overall health and the outcomes of the treatment.

Who Can Join the Study?

Sign a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
Be able to follow the study’s rules and procedures.
Be able to swallow tablets and capsules whole.
Have acceptable organ function, which means your organs are working well enough, as shown by specific lab tests.
Have acceptable blood function, meaning your blood cells are at healthy levels without recent transfusions or growth factors.
If you are a woman who can have children, you must have a negative pregnancy test before starting the study.
If you are a man with a female partner who can have children, you must use birth control during the study and for 6 months after, and you must not donate sperm during this time.
Any side effects from previous treatments or surgeries must have improved to a mild level.
If you had radiation therapy before, it must have been completed at least 7 days before starting the study, and you must have recovered from any immediate side effects.
You must have a life expectancy of at least 12 weeks, as judged by the study doctor.
For certain parts of the study, you must be able to eat a high-fat meal and fast for 12 hours.
You must be at least 12 years old. If you are between 12 and 17 years old, you can join only after some adults have completed a treatment cycle.
You must have a certain level of physical activity and ability, measured by specific performance scores.
You must have advanced or resistant solid tumors. If you are under 18, you can join only if there is no standard treatment available. If you are 18 or older, you can join if standard treatments are not suitable or if you choose not to have them.
If you are under 18, you must weigh at least 40 kg (about 88 pounds).
You must have a sample of your tumor tissue available for testing, or a tumor that can be safely biopsied if no sample is available.
Your tumor must have specific genetic changes, confirmed by a certified laboratory.
Certain types of endometrial cancer are eligible, with specific genetic characteristics confirmed by tests.
Your disease must be measurable according to specific criteria used in clinical studies.

Who Cannot Join the Study?

Patients who have a different type of cancer that is not an advanced solid tumor with specific genetic changes.
Patients who are not able to safely take the study medication due to other health conditions.
Patients who are currently pregnant or breastfeeding.
Patients who are participating in another clinical trial that might interfere with this study.
Patients who have had a recent major surgery or are recovering from a major surgery.
Patients who have an active infection that requires treatment.
Patients who have a history of severe allergic reactions to similar medications.
Patients who have certain heart conditions that could be affected by the study medication.
Patients who have not recovered from side effects of previous cancer treatments.
Patients who have a history of drug or alcohol abuse that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Rigshospitalet	Copenhagen	Denmark
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Uypjhauoaepw Mzhvqqi Cmjsmlj Gmdqnlrto	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2021
France	Not yet recruiting	01.06.2021
Spain	Not yet recruiting	01.06.2021
The Netherlands	Not recruiting	01.06.2021

Trial locations

Investigated drugs:

RP-6306 is a medication being studied for its safety and how well it is tolerated in patients with advanced solid tumors. The trial aims to find the best dose and schedule for using RP-6306 alone. It is also being tested in combination with other medications to see if it can be more effective.

RP-3500 is another medication used in combination with RP-6306. The study is looking at how safe and tolerable this combination is for patients with specific types of advanced solid tumors. The goal is to find the best dose and schedule for this combination.

Debio 0123 is a medication being tested in combination with RP-6306. This combination is being studied for its safety and tolerability in patients with certain genetic changes in their tumors. The trial also aims to find the best dose and schedule for this combination and to see if it can help reduce tumor size in specific types of cancer.

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 symptoms such as pain, swelling, or dysfunction of the affected organ. The genetic makeup of the tumor, such as CCNE1 amplification or mutations in genes like FBXW7, can influence its behavior and response to treatment.

Trial ID:

2023-510063-35-00

Protocol code:

Debio 0123-106

NCT ID:

NCT04855656

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study on the Safety of RP-6306 Alone or with RP-3500 or Debio 0123 for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?