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A Study of CRN09682 for Patients with Neuroendocrine Tumors and Other Solid Tumors that Express Somatostatin Receptor Type 2

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study involves people with neuroendocrine neoplasms or other solid tumors that have spread to other parts of the body or cannot be removed by surgery. Neuroendocrine neoplasms are cancers that develop from cells that release hormones into the blood. The disease being studied must express a specific protein called somatostatin receptor type 2, which is found on the surface of some cancer cells. The treatment being tested is CRN09682, which is given as an injection into a vein. This medication works by attaching to the somatostatin receptor type 2 on cancer cells.

The purpose of the study is to check the safety of CRN09682 and to see how well it works in treating these types of cancers. The study has two main parts. In the first part, different amounts of the medication will be tested in small groups of people to find out which dose is safe and appropriate to use. In the second part, a larger group of people will receive the dose that was selected from the first part to learn more about its safety and effectiveness. During the study, doctors will monitor for any side effects and will check how the cancer responds to the treatment.

People joining this study will have regular medical visits where they will receive the study medication and undergo tests to check their health and see how their cancer is responding. The study will look at whether the tumors get smaller, stay the same size, or grow, and will measure how long any positive effects last. Blood samples will be taken to measure the levels of CRN09682 and MMAE in the body. MMAE is a substance that is part of how the medication works against cancer cells. The study will also use special imaging tests that can detect somatostatin receptors to see changes in the tumors over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening and Confirmation

    Your medical history will be reviewed to confirm that you have a diagnosis of metastatic (cancer that has spread to other parts of the body) or locally advanced (cancer that has grown beyond its original site but has not spread to distant parts of the body) disease that cannot be removed by surgery.

    Your tumor tissue will be examined under a microscope to confirm the diagnosis of neuroendocrine tumor (a type of cancer that develops from cells that release hormones into the blood), neuroendocrine carcinoma, or other solid tumor types.

    Imaging scans will be reviewed to confirm that your disease has grown or progressed based on RECIST version 1.1 (a standard method used to measure tumor size and response to treatment).

    You will undergo somatostatin receptor imaging (a special scan that shows whether your tumor has specific proteins called somatostatin receptors on its surface) to confirm that your tumor expresses these receptors.

    The imaging will also confirm that you have at least one tumor location that can be measured according to RECIST version 1.1 criteria.

  2. Step 2

    Treatment Assignment

    You will be assigned to receive CRN09682, which is an experimental medication being tested in this study.

    The study has two phases: a Dose Escalation Phase and a Dose Expansion Phase.

    If you enter during the Dose Escalation Phase, you will receive a specific dose level of CRN09682 that is being tested for safety. Different groups of participants receive different dose levels.

    If you enter during the Dose Expansion Phase, you will receive the dose of CRN09682 that was selected based on the results from the Dose Escalation Phase.

  3. Step 3

    Receiving the Study Medication

    You will receive CRN09682 as an intravenous infusion (given directly into a vein through a needle or tube).

    The medication is prepared as a solution for injection.

    The specific dosage, frequency of administration, and duration of treatment will be determined based on which phase of the study you are in and how you respond to the medication.

    Your healthcare team will monitor you during each infusion.

  4. Step 4

    Safety Monitoring During Treatment

    Throughout the study, you will be monitored for any adverse events (unwanted or harmful effects that may occur during treatment).

    If you are in the Dose Escalation Phase, you will be closely watched for dose-limiting toxicities (serious side effects that may require stopping or reducing the dose of medication).

    Blood samples will be collected at specific times to measure the levels of CRN09682 and MMAE (a component of the study drug) in your blood. This is called pharmacokinetic testing and helps understand how your body processes the medication.

    Blood samples will be taken before each dose and at the end of infusion to measure drug concentrations.

    Any side effects that lead to interruption or stopping of the study medication will be recorded.

  5. Step 5

    Tumor Response Assessment

    You will have regular imaging scans to assess how your tumor is responding to the treatment.

    The scans will be evaluated using RECIST version 1.1 criteria to determine if your tumor has shrunk, stayed the same size, or grown.

    The possible responses include: complete response (all tumors have disappeared), partial response (tumors have shrunk by at least 30%), stable disease (tumors have neither grown significantly nor shrunk significantly), or progressive disease (tumors have grown).

    Additional somatostatin receptor imaging may be performed during the Dose Expansion Phase to assess changes in receptor expression.

    The time from when your tumor responds to treatment until it grows again will be measured. This is called duration of response.

    The time from when you start treatment until your disease progresses will also be measured. This is called progression-free survival.

  6. Step 6

    Ongoing Treatment and Follow-up

    You will continue to receive CRN09682 as long as the treatment is helping you and you are not experiencing unacceptable side effects.

    Regular visits will be scheduled to monitor your health, assess side effects, and evaluate how your tumor is responding.

    If your disease progresses or if you experience side effects that cannot be managed, treatment may be stopped.

    Your participation in the treatment phase will continue according to the study protocol and your individual response to therapy.

Who can join the trial?

5 criteria

  • You must have a confirmed diagnosis through tissue examination of metastatic (cancer that has spread to other parts of the body) or locally advanced (cancer that has grown beyond its original location but has not spread far) cancer that cannot be removed by surgery. This includes neuroendocrine tumors (a type of cancer that develops from cells that release hormones into the blood), neuroendocrine carcinomas (a more aggressive form of neuroendocrine cancer), or other solid tumors that have been shown to be growing on imaging scans.
  • You must have at least one tumor location that can be measured on imaging scans according to specific evaluation criteria.
  • Your tumor must show the presence of somatostatin receptors (proteins on the surface of certain cancer cells) confirmed by special imaging tests that detect these receptors.
  • You must be an adult to participate in this study.
  • Both male and female patients can participate in this study.

Who cannot join the trial?

3 criteria

  • The study does not list specific exclusion criteria in the provided information, which means detailed reasons why patients cannot participate are not available in this document
  • Generally, you should discuss with your doctor whether this study is appropriate for you based on your individual medical situation
  • Your doctor will need to review the complete study requirements to determine if you are eligible to participate
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Investigated drugs

CRN09682 is an investigational medication being studied in this clinical trial. It is designed to target and treat tumors that express a specific protein called somatostatin receptor type 2 (SST2). This medication is being tested in patients with neuroendocrine neoplasms and other solid tumors that have this receptor. The study will evaluate how safe the medication is and how well patients tolerate it at different dose levels.

What is already known about the treatment

CRN09682 – CRN09682 is an experimental medication currently being tested in clinical trials for the treatment of advanced cancers that have a specific protein marker called somatostatin receptor type 2 (SST2) on their surface, particularly neuroendocrine tumors that have spread or cannot be removed by surgery. The drug works by targeting and binding to the SST2 protein on cancer cells, which allows it to deliver treatment directly to these cells while potentially sparing healthy tissue. This medication is still in early-phase research (Phase 1/2 trials) to determine the safest and most effective dose, and it has not yet been approved for general medical use. It belongs to a class of targeted cancer therapies designed to attack tumors that express specific molecular markers.

Investigated diseases

Neuroendocrine Neoplasms – Neuroendocrine neoplasms are tumors that develop from cells that release hormones into the bloodstream in response to signals from the nervous system. These tumors can occur in various parts of the body, most commonly in the digestive system, pancreas, and lungs. The cells in these tumors have features of both nerve cells and hormone-producing cells. Neuroendocrine neoplasms can be slow-growing or fast-growing depending on their type. Some of these tumors produce excess hormones, which can cause various symptoms throughout the body. The disease can progress locally or spread to other parts of the body through a process called metastasis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-521672-60-00Protocol codeCRN09682-191Estimated enrolment143 patientsSponsorCrinetics Pharmaceuticals Inc.

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