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Study on the Safety and Efficacy of CR6086 and Balstilimab for Patients with Pretreated Metastatic Colorectal and Other GI Cancers

Fast replyInvestigationalNo placebo
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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 effects of a new treatment combination for patients with certain types of advanced cancers. The diseases being studied include metastatic colorectal cancer and other metastatic gastrointestinal cancers. These are cancers that have spread to other parts of the body and are known to be difficult to treat. The treatment being tested combines two medications: CR6086, which is an immunomodulator, and Balstilimab (also known by its code name AGEN2034), which is a type of medication called a PD-1 inhibitor. PD-1 inhibitors help the immune system recognize and attack cancer cells.

The purpose of this study is to evaluate the safety and effectiveness of this combination treatment. Participants in the study will receive both medications, with CR6086 taken as a capsule by mouth and Balstilimab given as an infusion into a vein. The study will monitor patients over a period of 24 weeks to see how well the treatment works and to check for any side effects. The goal is to determine if this combination can help control the disease in patients who have already received other treatments.

Throughout the study, doctors will assess the safety of the treatment by observing any side effects and changes in health. They will also measure how well the treatment works by looking at the disease control rate, which includes the number of patients whose cancer shrinks, disappears, or remains stable. This study aims to provide new insights into treating these challenging cancers and potentially offer a new option for patients 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

    Initiation of treatment

    Upon joining the study, the treatment begins with the administration of two medications: CR6086 and Balstilimab.

    CR6086 is provided in capsule form for oral use. The specific dosage and frequency will be determined by the study protocol.

    Balstilimab is administered as a solution for infusion, which means it is given intravenously. The dosage and frequency are also determined by the study protocol.

  2. Step 2

    Treatment duration

    The treatment is planned to continue for a period of 24 weeks. This duration may vary if there is a need to discontinue earlier based on individual circumstances.

  3. Step 3

    Monitoring and assessments

    Throughout the treatment period, regular monitoring will occur to assess the safety and tolerability of the medication combination.

    Assessments will include clinical laboratory tests, vital signs, performance status evaluations, and physical examinations.

    The effectiveness of the treatment will be evaluated by measuring the disease control rate, which includes complete response, partial response, or stable disease.

  4. Step 4

    Completion of treatment

    After completing the 24-week treatment period, or earlier if necessary, a final assessment will be conducted to evaluate the overall response to the treatment.

    This assessment will include a review of any adverse events experienced during the trial and the overall health status of the patient.

Who can join the trial?

15 criteria

  • Must sign and date an informed consent form before any study-specific procedures. This means you agree to participate and understand what the study involves.
  • Must have an ECOG performance status of 1 or less. This is a scale that measures your ability to perform daily activities, with 0 being fully active and 5 being deceased.
  • Must have an anticipated life expectancy of at least 3 months.
  • Must have adequate blood and organ function, shown by specific lab results taken within 7 days before starting the study treatment. This includes having enough red blood cells, white blood cells, and platelets, as well as proper kidney and liver function.
  • Must be willing and able to follow all study requirements.
  • Must be 18 years or older.
  • Must weigh more than 40 kg (about 88 pounds).
  • Must have a confirmed diagnosis of advanced-stage cancer that cannot be removed by surgery.
  • Must have Stage IV cancer, which means the cancer has spread to other parts of the body.
  • Must have failed at least one previous chemotherapy treatment for metastatic disease, or have had the disease return or progress after surgery and chemotherapy.
  • Must have measurable disease according to RECIST v1.1, which is a set of guidelines used to measure how well a cancer treatment is working.
  • Must not have been treated with EP4 receptor antagonists before. These are drugs that block certain signals in the body.
  • Must have a sufficient sample of tumor tissue available for testing.
  • Must not have been treated with drugs that target immune checkpoints or EP4 receptor antagonists before. Immune checkpoints are proteins that help regulate the immune system.
  • Must have a specific type of colorectal cancer known as pMMR/MSS, which means the cancer has certain proteins intact and shows stability in genetic markers.

Who cannot join the trial?

8 criteria

  • Patients who have not been previously treated for their cancer.
  • Patients with cancers that are not mismatch-repair-proficient or microsatellite stable. These are specific characteristics of cancer cells that affect how they grow and respond to treatment.
  • Patients with cancers that are not located in the gastrointestinal (GI) tract. The GI tract includes organs like the stomach and intestines.
  • Patients who are not able to complete 24 weeks of treatment.
  • Patients who have serious health conditions that could make the treatment unsafe for them.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • CR6086

    is an EP4 receptor antagonist. It works by blocking a specific receptor in the body that is involved in inflammation and cancer progression. In this trial, it is being tested to see if it can help treat certain types of metastatic colorectal cancer and other gastrointestinal cancers when used in combination with another medication.

  • Balstilimab (AGEN2034)

    is a PD-1 inhibitor. It helps the immune system recognize and attack cancer cells by blocking a pathway that cancer cells use to hide from the immune system. In this trial, it is used in combination with CR6086 to evaluate if the two medications together can improve treatment outcomes for patients with specific types of metastatic cancers.

What is already known about the treatment

  • CR6086

    This medication is administered orally and is currently being studied in clinical trials for its potential use in treating certain types of metastatic colorectal and gastrointestinal cancers. It is an EP4 receptor antagonist, which means it works by blocking the EP4 receptor, a part of the prostaglandin E2 pathway, potentially reducing inflammation and tumor growth. CR6086 is being evaluated for its safety and effectiveness when used in combination with immune checkpoint inhibitors, specifically in patients with cancers that are mismatch-repair-proficient and microsatellite stable.

  • Balstilimab (AGEN2034)

    This medication is given through intravenous infusion and is under investigation in clinical trials for its role in treating metastatic colorectal and gastrointestinal cancers. It is a PD-1 inhibitor, which helps the immune system recognize and attack cancer cells by blocking the PD-1 pathway, a mechanism that tumors use to evade immune detection. Balstilimab is being tested for its safety and preliminary effectiveness in combination with other treatments, aiming to improve disease control in patients with specific types of cancer.

Investigated diseases

  • Metastatic Colorectal Cancer

    This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs. The disease is characterized by the growth of malignant cells that can invade surrounding tissues and form new tumors in other areas. As it advances, symptoms may include changes in bowel habits, abdominal pain, and weight loss. The progression can vary, with some cases spreading more rapidly than others.

  • Metastatic Gastrointestinal Cancers

    These cancers originate in the gastrointestinal tract, which includes the stomach, liver, pancreas, and intestines, and have spread to other parts of the body. The disease progresses as cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in distant organs. Symptoms can vary depending on the location of the primary tumor and may include abdominal pain, nausea, and changes in appetite. The spread of these cancers can lead to complications in multiple organ systems. The progression is influenced by factors such as the type of primary cancer and the patient's overall health.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515446-16-00Protocol codeCR6086-1-04Estimated enrolment55 patientsSponsorRottapharm Biotech S.r.l.

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