Study of OMX-0407 for Patients with Previously Treated Unresectable Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called OMX-0407, which is a type of medication known as a salt-inducible kinase inhibitor. The study is aimed at patients who have previously been treated for certain types of cancer that cannot be surgically removed, known as unresectable solid tumors. These include specific cancers such as clear cell renal cell carcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and angiosarcoma. The purpose of the study is to explore how safe and tolerable OMX-0407 is for patients, as well as to understand how the body processes the drug.

The study is divided into two main parts. In the first part, the focus is on finding the right dose of OMX-0407 that patients can take safely. This involves gradually increasing the dose to see how much can be given without causing severe side effects. In the second part, the study looks at how well the drug works in treating the cancers mentioned earlier. This includes measuring how long the treatment can keep the cancer from getting worse and how it affects the patients’ quality of life.

Participants in the study will take OMX-0407 in capsule form by mouth. The study will monitor the patients over a period to see how they respond to the treatment and to check for any side effects. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of OMX-0407. The study aims to provide valuable information that could lead to new treatment options for patients with these types of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and previous treatments.

Informed consent is required to participate in the study.

2 dose escalation phase

The primary goal is to identify the dose-limiting toxicities (DLTs) of OMX-0407.

Secondary goals include determining the maximum tolerated dose (MTD) and the recommended dose for the next phase.

Safety and how the body processes the medication are also evaluated.

3 medication administration

OMX-0407 is administered orally in capsule form.

The dosage and frequency are adjusted based on the findings from the dose escalation phase.

4 cohort expansion phase

The primary goal is to assess the response rate of OMX-0407 in specific cancer types.

Secondary goals include measuring the duration of response, progression-free survival, overall survival, and quality of life.

Safety and how the body processes the medication continue to be evaluated.

5 tumor assessments

Tumor assessments are conducted at the start and every 12 weeks thereafter.

For certain cancer types, images are independently reviewed to determine response.

6 end of study

The study is estimated to conclude by June 28, 2025.

Final assessments and data collection are completed to evaluate the overall outcomes of the trial.

Who Can Join the Study?

Must be at least 18 years old (16 years for certain conditions) and agree to participate in the study.
Must have a type of cancer called clear cell renal cell carcinoma (ccRCC) confirmed by a test. If the cancer has mixed types, at least 70% should be clear cell type.
If there is involvement of blood vessels in the kidneys, the patient should be on stable blood-thinning medication before starting the study treatment. A biopsy, which is a small sample of tissue, should be done before starting the blood-thinning medication.
Must have had previous treatment that included PD-1 blockade and VEGFR inhibition. These are specific types of cancer treatments.
Must have a type of lung cancer called squamous non-small cell lung cancer (sqNSCLC) confirmed by a test. If the cancer has mixed types, it should mostly be squamous type.
Must have had previous treatment that included PD-1 blockade and platinum chemotherapy. These are specific types of cancer treatments.
If there are known genetic changes in the cancer, like EGFR mutations or ALK rearrangements, the patient must have received specific treatments for these changes.
Must have a type of cancer called urothelial carcinoma (UC) confirmed by a test.
Must have had previous treatment that included platinum-based chemotherapy, PD-1 blockade, and a treatment targeting Nectin A4.
Must have a type of cancer called angiosarcoma (AS) confirmed by a test, which is advanced or cannot be removed by surgery.
The cancer should be getting worse.
Must have confirmation of advanced cancer through a test.
Must have had at least one previous treatment for cancer that included a taxane or an anthracycline, which are types of chemotherapy drugs.
Must agree to have small samples of the tumor taken before and during the study treatment, unless it is not safe for health reasons.
Must provide previous tumor samples or agree to have a new sample taken during the screening process.
Must have completed or be unsuitable for standard treatments for their type of cancer, unless these treatments are not available locally. Must have had at least one previous treatment for the cancer type being studied.
Must have a performance status of 0, 1, or 2 according to the ECOG scale, which measures how well a person can perform daily activities. For certain phases of the study, the status should be 0 or 1.
Must be able to swallow pills and not have any issues with absorbing food or medicine in the stomach and intestines.
If of childbearing potential, must agree to use two forms of effective birth control during the study and for a period after the study ends. This applies to both male and female participants.
Any side effects from previous cancer treatments must have improved to a mild level or be stable.
Must have a tumor that can be evaluated using specific criteria called RECIST 1.1. For certain phases of the study, the disease must be measurable.

Who Cannot Join the Study?

Patients who have not been previously treated for their solid tumors cannot participate.
Patients with tumors that can be surgically removed are not eligible.
Individuals under the age of 18 are excluded from the study.
Pregnant or breastfeeding women are not allowed to participate.
Patients with serious uncontrolled medical conditions, such as severe heart disease, are excluded.
Individuals with a history of severe allergic reactions to similar medications are not eligible.
Patients currently participating in another clinical trial are not allowed to join this study.
Individuals with active infections that require treatment are excluded.
Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
Individuals with mental health conditions that could affect their ability to follow study instructions are excluded.

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
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
MD Anderson Cancer Center	Madrid	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Cgeegknzb Ufawztdauxvtok Scwkshfza	Woluwe-Saint-Lambert	Belgium
Ijrxirwt Rmzrmcqy Dd Cugzca Dj Mfxvakaykdr	Montpellier	France
Csydrx Lobv Bbjcul	Lyon	France
Izoouuid Czpvur Dlobsgsrcikzpcjak	L'hospitalet De Llobregat	Spain
Airolcprvj Pzeiolzl Hqriiccf Dv Mkpdqiwbp	Marseille	France
Hxbehyfl Vcqy deuaigxt	Barcelona	Spain
Cptqea Oirqj Lwevnyr	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.11.2022
France	Not recruiting	01.11.2022
Spain	Not recruiting	01.11.2022

Trial locations

Investigated drugs:

Omx-0407

OMX-0407 is a new medication being studied for its potential to treat patients with solid tumors that cannot be removed by surgery and have already been treated with other therapies. It works by inhibiting a specific enzyme called salt-inducible kinase, which may help to stop or slow down the growth of cancer cells. The study aims to find the best dose of OMX-0407 that patients can tolerate and to understand how the body processes the medication. Researchers are also looking at how effective OMX-0407 is in shrinking tumors and improving patients’ quality of life.

Investigated diseases:

Neoplasm

Unresectable Solid Tumors – These are abnormal masses of tissue that cannot be surgically removed due to their location, size, or involvement with vital structures. They can occur in various organs and are characterized by uncontrolled cell growth. As the disease progresses, these tumors may grow larger and potentially spread to other parts of the body. The progression can lead to symptoms depending on the tumor’s location, such as pain, obstruction, or organ dysfunction. The growth rate and behavior of these tumors can vary widely, influencing the overall impact on the body.

Trial ID:

2024-514554-75-00

Protocol code:

OMX-0407-101

NCT ID:

NCT05826600

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study of OMX-0407 for Patients with Previously Treated Unresectable Solid Tumors

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