Study on the Safety and Effectiveness of AZD0022 Alone and with Other Cancer Drugs for Adults with KRAS-G12D Mutated Tumors in Lung, Colorectal, and Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying certain types of cancer, specifically Non-Small Cell Lung Cancer, Colorectal Cancer, and Pancreatic Ductal Adenocarcinoma. The study is investigating a new treatment called AZD0022, which is a type of medication taken as a film-coated tablet. The trial will explore how safe and effective AZD0022 is when used alone and in combination with other cancer treatments. The study is particularly interested in patients whose tumors have a specific genetic change known as the KRAS-G12D mutation.

The purpose of the study is to learn more about the safety and potential benefits of AZD0022 for people with these cancers. Participants will receive the medication and be monitored to see how their bodies respond. Some participants may receive AZD0022 alone, while others may receive it alongside other cancer drugs. The study will also look at how the drug moves through the body over time. This information will help researchers understand the best way to use AZD0022 in treating these cancers.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their cancer. The study will also collect information on any side effects experienced by participants. This trial is an important step in finding new ways to treat cancers with the KRAS-G12D mutation and could lead to new treatment options for patients in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of a KRASG12D mutation in the tumor, which can be identified through a pre-existing test result or a new test if necessary.

A comprehensive review of medical history and current health status is performed to ensure all criteria are met.

2 treatment initiation

The treatment phase begins with the administration of AZD0022 as a monotherapy or in combination with other anti-cancer agents. The specific regimen depends on the part of the study the participant is enrolled in.

For oral administration, AZD0022 is provided in the form of film-coated tablets. The dosage and frequency are determined based on the study protocol.

3 monitoring and evaluation

Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes checking vital signs, laboratory parameters, and performing ECGs.

Participants are evaluated for any adverse effects or significant changes in health status. Adjustments to the treatment may be made based on these evaluations.

4 dose escalation and optimization

In certain parts of the study, dose escalation is performed to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of AZD0022.

Participants may undergo additional assessments to optimize the dosage for maximum efficacy and minimal side effects.

5 efficacy assessment

The anti-tumor activity of AZD0022 is assessed through imaging studies and other diagnostic tests to evaluate the response of the tumor to the treatment.

The overall response rate (ORR) and other measures of efficacy are determined according to standardized criteria.

6 completion and follow-up

Upon completion of the treatment phase, participants undergo a final evaluation to assess the overall impact of the treatment.

Long-term follow-up may be conducted to monitor the participant’s health and any lasting effects of the treatment.

Who Can Join the Study?

Must be able to give signed informed consent, which means agreeing to follow the study rules and understanding what the study involves.
Must be at least 18 years old or the legal age of consent in the area where the study is happening.
Must have a confirmed advanced or spreading tumor, which means the cancer has grown or spread to other parts of the body.
Must have a specific genetic change in the cancer called a KRASG12D mutation. This can be confirmed by a test done before or during the study.
Must have tried standard treatments for their type of cancer and either not responded, stopped working, or couldn’t tolerate them.
Must provide a sample of the tumor for testing.
Must have at least one measurable tumor that can be tracked during the study.
Must have organs and bone marrow that are working well enough, as shown by specific medical tests.
For certain parts of the study, must be willing to provide additional tumor samples and be in a stable condition to handle the procedure.
For some parts of the study, must be able to eat a high-fat meal and fast for a certain period as part of the study requirements.

Who Cannot Join the Study?

Patients who do not have advanced tumors with a specific genetic change called a KRASG12D mutation cannot participate. This mutation is a change in a gene that can affect how cancer grows.
Patients who are not diagnosed with one of the following cancers: Non-Small Cell Lung Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma cannot participate. These are specific types of cancer affecting the lungs, colon, and pancreas.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to safely tolerate the study treatment cannot participate. This means if the treatment could cause harm or severe side effects, they will not be included.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate. This includes groups like children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Netherlands Cancer Institute	Amsterdam	The Netherlands
Icdteccb Ckcobe Dxzdfetoqhurayiee	L'hospitalet De Llobregat	Spain
Wmartnvebek Wfxmngxndjnrwlmjcgoi Cdpudge Obsxamixc I Tjufaiplyoosq Iz Mhafllsygin W Ldlad	Lodz	Poland
Upyniszofmrdyi Ccaufht Khbeokhyx	Gdansk	Poland
Uytvyolake Od Atmoofd	Edegem	Belgium
Hqnglllz Vngz dscrljfw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2025
Italy	Not recruiting	01.04.2025
Poland	Not recruiting	01.04.2025
Spain	Not recruiting	01.04.2025
The Netherlands	Not recruiting	01.04.2025

Trial locations

Investigated drugs:

AZD0022 is an investigational medication being studied for its potential to treat advanced tumors that have a specific genetic mutation known as KRASG12D. This medication is being tested both on its own and in combination with other anti-cancer drugs to see how well it works and how safe it is for patients. The study aims to find the best dose that patients can tolerate while also looking at how effective the medication is in shrinking or controlling the tumors.

Investigated diseases:

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease progresses through stages, beginning with localized tumors and potentially advancing to more widespread metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression can vary significantly among individuals, influenced by factors such as genetic mutations and overall health.

Colorectal Cancer – This cancer affects the colon or rectum, often starting as benign polyps that can become cancerous over time. It can grow into the wall of the colon or rectum and spread to nearby lymph nodes and other organs. Symptoms might include changes in bowel habits, blood in the stool, and abdominal discomfort. The disease progresses through stages, from localized growths to more advanced metastatic disease. Early detection is crucial for managing its progression.

Pancreatic Ductal Adenocarcinoma – This is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It tends to grow and spread quickly, often reaching advanced stages before detection. Symptoms can include jaundice, weight loss, and abdominal pain. The disease progresses as the cancer cells invade nearby tissues and organs, and potentially spread to distant sites. Its aggressive nature makes early detection challenging.

Trial ID:

2024-516699-14-00

Protocol code:

D7080C00001

NCT ID:

NCT06599502

Trial Phase:

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

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Study on the Safety and Effectiveness of AZD0022 Alone and with Other Cancer Drugs for Adults with KRAS-G12D Mutated Tumors in Lung, Colorectal, and Pancreatic Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?