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Study on the Effectiveness and Safety of CAM2029 Compared to Octreotide and Lanreotide in Patients with Gastroenteropancreatic Neuroendocrine Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET). These are rare types of tumors that occur in the pancreas and gastrointestinal tract. The study will compare a new treatment called CAM2029 (octreotide subcutaneous depot) with two existing treatments: octreotide long-acting release (LAR) and lanreotide autogel (ATG). These treatments are given as injections and are designed to help manage the symptoms and progression of the disease.

The purpose of the study is to determine if CAM2029 is more effective than the other treatments in delaying the progression of the tumors. Participants in the study will receive one of these treatments and will be monitored over time to see how their condition changes. The study will involve regular check-ups and assessments to track the health and response of the participants to the treatment.

Throughout the study, participants will receive injections of the assigned treatment and may also receive a placebo. The study will last for a period of time, during which the health and quality of life of the participants will be closely observed. The goal is to gather information that could lead to better treatment options for people with GEP-NET in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be randomly assigned to one of the treatment groups. This means that the patient will receive one of the following medications: CAM2029 (octreotide subcutaneous depot), Somatuline Autogel (lanreotide), or SANDOSTATIN LAR (octreotide long-acting release).

  2. Step 2

    Treatment administration

    The patient will receive the assigned medication through an injection. CAM2029 is administered as a subcutaneous injection, which means it is injected under the skin. Somatuline Autogel is also given as a subcutaneous injection. SANDOSTATIN LAR is administered as an intramuscular injection, meaning it is injected into a muscle.

    The frequency and dosage of the medication will depend on the specific treatment group to which the patient is assigned. The duration of the treatment will be determined by the trial protocol and the patient's response to the medication.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient's health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging tests such as CT or MRI scans to assess the progression of the disease.

    The patient's quality of life and any side effects experienced will also be evaluated using questionnaires and other assessment tools.

  4. Step 4

    End of trial

    The trial is expected to continue until December 2026. At the end of the trial, the patient's overall health and the effectiveness of the treatment will be reviewed.

    The patient may be asked to participate in follow-up assessments to gather additional information about the long-term effects of the treatment.

Who can join the trial?

5 criteria

  • Must be a male or female who is 18 years or older.
  • Must have a confirmed diagnosis of advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET) that cannot be removed by surgery or have spread to other parts of the body.
  • Must have at least one tumor that can be measured and shows a higher uptake than the liver on a special scan called a somatostatin receptor imaging. This scan should be done within 12 months before joining the study.
  • If a special scan called FDG-PET CT is done for patients with a specific type of tumor (well-differentiated Grade 3 NET), it must show that areas of the disease are also visible on the somatostatin receptor imaging.
  • Must have an ECOG performance status of 0 to 2, which means the patient is fully active or has some restrictions but can still take care of themselves.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies to the study medications or similar drugs.
  • Patients who have had major surgery within the last 4 weeks.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse within the last year.
  • Patients who have a mental health condition that could affect their ability to participate in the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

  • Octreotide

    is a medication used to treat certain types of tumors in the digestive system, known as gastroenteropancreatic neuroendocrine tumors. It works by mimicking a natural hormone in the body that helps to control the growth of these tumors. In this trial, octreotide is used in two forms: a long-acting release (LAR) version, which is designed to be released slowly over time, and a subcutaneous depot version called CAM2029, which is injected under the skin and also releases the medication slowly.

  • Lanreotide

    is another medication used to treat gastroenteropancreatic neuroendocrine tumors. Like octreotide, it mimics a natural hormone in the body to help control tumor growth. In this trial, lanreotide is used in a form called autogel (ATG), which is a long-acting injection that releases the medication slowly over time to help manage the condition.

What is already known about the treatment

Octreotide subcutaneous depot (CAM2029) – This medication is administered as an injection under the skin and is currently being studied in clinical trials for its effectiveness and safety in treating gastroenteropancreatic neuroendocrine tumors. It is designed to improve progression-free survival in patients with these tumors, which are often difficult to remove surgically. Octreotide works by mimicking a natural hormone in the body that helps regulate the growth of certain types of cells, thereby slowing down tumor growth. It belongs to a class of drugs known as somatostatin analogs, which are used to manage symptoms and control tumor progression in neuroendocrine tumors.

Investigated diseases

Gastroenteropancreatic Neuroendocrine Tumors – These are a group of rare tumors that originate from neuroendocrine cells in the gastrointestinal tract and pancreas. They are characterized by their ability to produce hormones, which can lead to various symptoms depending on the hormones released. The progression of these tumors can vary, with some growing slowly over many years, while others may grow more rapidly. They are often well-differentiated, meaning the tumor cells look similar to normal cells under a microscope. As the disease advances, it can spread to other parts of the body, such as the liver or lymph nodes. The course of the disease can be unpredictable, with periods of stability followed by progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508723-12-00Protocol codeHS-19-657Estimated enrolment302 patientsSponsorCamurus AB

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).