Study on the Safety of PD L 506 for Patients with First-Time Colorectal Cancer and Healthy Individuals

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What is this study about?

This clinical trial is focused on studying colorectal cancer, a type of cancer that affects the colon or rectum. The study will use a treatment called PD L 506, which is a powder that is mixed with water to create an oral solution. The main goal of the study is to assess the safety and tolerability of this treatment in two groups: patients who have been newly diagnosed with colorectal cancer and healthy individuals without the disease.

Participants in the study will receive PD L 506 to see how their bodies react to it. For those with colorectal cancer, the treatment will be given multiple times, while healthy participants will receive it just once. The study will also measure the levels of certain substances called porphyrins in the urine, which may help in diagnosing the disease. These substances are naturally occurring in the body and can be affected by the treatment.

The study will take place over a period of time, with participants attending several visits to monitor their health and the effects of the treatment. The researchers will be looking for any side effects and changes in the levels of porphyrins in the urine to better understand the potential benefits and risks of using PD L 506 in treating colorectal cancer.

1 joining the study

Upon joining the study, you will have already provided your signed and dated informed consent. This means you have agreed to participate after receiving comprehensive information about the study.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes verifying that you are 18 years or older and, if applicable, confirming your diagnosis of colorectal cancer (CRC) or your status as a healthy subject.

3 medication administration

If you are a patient with CRC, you will receive repeated oral doses of 300 mg PD L 506. If you are a healthy subject, you will receive a single oral dose of 300 mg PD L 506.

4 urine sample collection

Urine samples will be collected to measure the concentration of certain substances called porphyrins. For CRC patients, samples will be taken before and after the administration of PD L 506 at various visits. For healthy subjects, samples will be collected before and 5 hours after the administration of PD L 506.

5 monitoring and follow-up

Throughout the study, you will be monitored for any adverse reactions to the medication. The number of adverse drug reactions and any discontinuations due to these reactions will be recorded.

6 completion of study

The study is expected to end by June 30, 2026. Your participation will conclude after all required follow-up visits and assessments are completed.

Who Can Join the Study?

Must provide a signed and dated informed consent form after receiving all necessary information about the study.
Must be a male or female who is 18 years of age or older.
For patients with Colorectal Carcinoma (CRC) in Cohort 1: Must have a newly diagnosed, non-spreading, and operable colorectal cancer. The cancer should not have spread to other parts of the body (less than stage IV). Must have a confirmed diagnosis through a tissue sample test and should not have started any cancer treatment.
For healthy participants in Cohort 2: Must have had a colonoscopy (a test to look inside the colon) that reached the beginning of the large intestine and showed no signs of cancer within the last 5 years before the screening visit. Must also have normal results for specific blood tests called CEA and CA19-9.
Women who can have children and men must agree to use highly effective birth control methods consistently and correctly during the study and until the last follow-up visit.
Women who can have children and have not yet gone through menopause must agree to take a pregnancy test that shows they are not pregnant within 72 hours before the first dose of the study medication and during the study as needed.

Who Cannot Join the Study?

Patients who have had more than one occurrence of Colorectal Carcinoma (a type of cancer that affects the colon or rectum) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are considered part of a vulnerable population, which means they might be at higher risk of harm or exploitation, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Muenchen Klinik gGmbH	Munich	Germany
Kjzeabmq dsz Ukxgxfblfomg Mgmqpkuz Awt	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	18.02.2025

Trial locations

Investigated drugs:

Aminolevulinic Acid Hydrochloride

PD L 506 is a medication being tested in this clinical trial to see if it is safe and well-tolerated when taken by mouth. The study is looking at how the body handles this medication in people who have just been diagnosed with colorectal cancer and in healthy people. Researchers are also interested in seeing if taking this medication affects certain substances in the urine, which might help in diagnosing or understanding the condition better. The trial involves giving the medication to people with colorectal cancer multiple times, while healthy participants receive it just once. This helps researchers compare the effects in different groups of people.

Colorectal Carcinoma – Colorectal carcinoma is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, benign clumps of cells called polyps that can develop into cancer over time. As the disease progresses, it can invade the walls of the colon or rectum and spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. The progression of the disease can vary, with some cases remaining localized while others may metastasize to distant organs. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2023-508668-31-00

Protocol code:

KRK 01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of PD L 506 for Patients with First-Time Colorectal Cancer and Healthy Individuals

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?