Study of AMG 193 and IDE397 for Adults with Advanced MTAP-null Solid Tumors and Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as , which are advanced cancers that lack a specific gene called MTAP. The study is particularly interested in a subtype of this cancer called (NSCLC). The trial will test the combination of two experimental drugs, and , to see how safe and effective they are when used together. These drugs are taken orally in the form of tablets or capsules.

The purpose of the study is to find the highest dose of these drugs that can be safely taken by participants with advanced MTAP-null solid tumors and to evaluate their effectiveness in treating MTAP-null NSCLC. The study will be conducted in two parts. In the first part, researchers will determine the maximum dose that is safe and tolerated. In the second part, they will assess how well the combination of AMG 193 and IDE397 works against the cancer.

Participants in the study will receive the study drugs and will be monitored for any side effects, changes in vital signs, and how their cancer responds to the treatment. The study will also measure the levels of the drugs in the blood to understand how they are processed by the body. The trial aims to provide valuable information on the potential benefits of this drug combination for people with these specific types of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as the presence of advanced MTAP-null solid tumors or MTAP-null Non Small-Cell Lung Cancer.

Participants must be able to swallow and retain oral medication and agree to record adherence to the treatment.

2 initial assessment

An initial assessment is conducted to measure the disease using specific criteria and to ensure adequate organ function.

If archived tumor tissue is not available, a biopsy may be required before starting the treatment.

3 treatment phase 1

In Part 1, the focus is on determining the maximum tolerated dose of AMG 193 in combination with IDE397.

Both medications are administered orally in tablet form. The dosage and frequency are adjusted to find the highest safe dose.

4 treatment phase 2

In Part 2, the study evaluates the anti-cancer activity of the combination treatment in participants with MTAP-null Non Small-Cell Lung Cancer.

The response to treatment is assessed using specific criteria to determine the effectiveness of the medication.

5 monitoring and evaluation

Throughout the study, participants are monitored for side effects, changes in vital signs, and other health indicators.

Blood levels of the medications are measured to understand how the body processes them.

6 end of study

The study is estimated to conclude by May 2026.

Final assessments are conducted to evaluate the overall response to the treatment and any long-term effects.

Who Can Join the Study?

The patient must have a specific genetic change called MTAP-null or MTAP deletion. This means a certain gene is missing or not working.
The patient must have an advanced or metastatic solid tumor. This means the cancer has spread and cannot be cured with standard treatments. For Part 1, the patient must have a solid tumor with MTAP-null or lost MTAP expression for which no standard therapy exists. For Part 2, the patient must have MTAP-null or lost MTAP expression Non-Small Cell Lung Cancer (NSCLC) that has worsened after 1 to 2 previous treatments.
The patient must be able to swallow and keep down the study medicine taken by mouth and be willing to keep track of taking the study medicine.
The patient’s disease must be measurable according to a specific guideline called RECIST v1.1. This means the cancer can be measured in a way that is standard for research.
The patient must have adequate organ function. This means the organs like the liver and kidneys are working well enough, as defined in the study rules.
The patient must have archived tumor tissue available. If not, the patient may still join the study by having a tumor biopsy before starting the study treatment.
The patient must be an adult, as the study is for adult participants.
Both male and female patients can participate in the study.
The study does not include vulnerable populations, meaning it is not designed for groups that need special protection.

Who Cannot Join the Study?

Patients who do not have advanced MTAP-null solid tumors or advanced MTAP-null Non Small-Cell Lung Cancer cannot participate.
Patients who are not adults cannot participate. This means the study is only for people who are 18 years or older.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like pregnant women, children, or people who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Rigshospitalet	Copenhagen	Denmark
Ibcgyqiv Cuzisv Djmxgzmihmgyjcasp	L'hospitalet De Llobregat	Spain
Hulxxtrp Vjse dtdgtefa	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.12.2024
Spain	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

AMG 193 is a medication being studied for its potential to treat advanced solid tumors that lack a specific gene called MTAP. In this trial, researchers are looking at how well AMG 193 works when used together with another medication, IDE397. They are also studying the highest dose of AMG 193 that can be safely given to patients.

IDE397 is another medication involved in this study. It is being tested in combination with AMG 193 to see if it can help treat advanced solid tumors that are missing the MTAP gene. The trial aims to find out if using IDE397 with AMG 193 can effectively fight cancer in patients with these specific types of tumors.

Investigated diseases:

Non-small cell lung cancer

MTAP-null Solid Tumors – MTAP-null solid tumors are a type of cancer characterized by the absence of the MTAP gene, which is involved in cellular metabolism. These tumors can occur in various organs and tissues, leading to abnormal growth and division of cells. As the disease progresses, the tumors may grow larger and potentially spread to other parts of the body. The lack of the MTAP gene can influence the tumor’s behavior and response to certain treatments. This condition is not classified as a rare disease, indicating it occurs with some frequency in the population. The progression of these tumors can vary depending on the specific location and type of the tumor.

MTAP-null Non-Small Cell Lung Cancer (NSCLC) – MTAP-null Non-Small Cell Lung Cancer is a subtype of lung cancer where the MTAP gene is missing, affecting the cancer cells’ metabolism. This type of cancer typically starts in the tissues of the lungs and can lead to symptoms such as coughing, chest pain, and difficulty breathing. As the disease advances, the cancer may spread to other areas of the body, complicating the condition. The absence of the MTAP gene can impact the growth and spread of the cancer cells. This form of lung cancer is not considered rare, suggesting it is relatively common among lung cancer cases. The progression of the disease can vary based on individual factors and the specific characteristics of the cancer.

Trial ID:

2023-504364-42-00

Protocol code:

20220127

NCT ID:

NCT05975073

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of AMG 193 and IDE397 for Adults with Advanced MTAP-null Solid Tumors and Non-Small Cell Lung Cancer

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