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Study on TTX-030, Budigalimab, and Chemotherapy for Untreated Metastatic Pancreatic Cancer Patients

Verified siteRegistered drugNo 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 treatment of metastatic pancreatic adenocarcinoma, a type of cancer that has spread from the pancreas to other parts of the body. The study will explore the effectiveness and safety of a new treatment combination involving the investigational drug TTX-030 and chemotherapy, with or without the addition of another investigational drug called Budigalimab. The chemotherapy regimen includes two drugs: nab-paclitaxel and gemcitabine. These treatments will be compared to chemotherapy alone to see if the new combinations offer any additional benefits.

The purpose of this study is to evaluate whether adding TTX-030, with or without Budigalimab, to the standard chemotherapy regimen can improve outcomes for patients who have not received prior treatment for their metastatic pancreatic cancer. Participants in the study will be randomly assigned to one of three groups: one group will receive TTX-030 and chemotherapy, another group will receive TTX-030, Budigalimab, and chemotherapy, and the third group will receive only the chemotherapy. The study will monitor participants over a period of time to assess the progression of the disease and any side effects experienced.

Throughout the study, participants will receive their assigned treatments through intravenous infusion, which means the medication will be delivered directly into a vein. The study aims to provide valuable information on whether these new treatment combinations can help manage metastatic pancreatic cancer more effectively than the current standard chemotherapy alone. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather data on the treatment's impact on their cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of three treatment groups. Each group will receive a different combination of medications to evaluate their effectiveness and safety in treating metastatic pancreatic adenocarcinoma.

  2. Step 2

    Treatment administration

    The treatment involves the administration of medications through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

    The medications used in the study include paclitaxel, budigalimab, gemcitabine hydrochloride, and ttx-030. The specific combination and dosage will depend on the group to which the patient is assigned.

  3. Step 3

    Treatment schedule

    The treatment is administered on a regular schedule, which will be explained in detail by the healthcare team. The frequency and duration of each medication will vary based on the treatment group.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess the progression of the disease and any side effects of the treatment.

  5. Step 5

    End of treatment

    The study is expected to continue until February 2027. The duration of participation for each patient may vary depending on individual response to the treatment and other factors.

Who can join the trial?

18 criteria

  • Must be able to give signed informed consent, agreeing to follow the study's requirements and restrictions.
  • Must weigh at least 35 kg (about 77 pounds).
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to the way they were before treatment, except for mild hair loss or mild nerve damage.
  • Women who can have children and all men must agree to use two highly effective birth control methods for 6 months after the last study treatment.
  • If there is a history of heart failure, a heart test must show a heart function of at least 45% within 28 days before starting the study treatment.
  • Must meet certain blood test requirements, including:
    • Enough white blood cells and platelets.
    • Normal blood clotting, unless on stable blood-thinning medication.
    • Good kidney function.
    • Liver tests within acceptable limits.
    • Enough protein in the blood.
    • Must be 18 years or older at the time of screening.
    • Must have a confirmed diagnosis of metastatic pancreatic cancer.
    • No previous treatment for metastatic cancer, but previous treatment before cancer spread is allowed if there was no disease progression within 6 months after the last treatment.
    • No previous treatment with drugs that specifically target the immune system to fight cancer.
    • Must have measurable disease as determined by the study doctor.
    • Must be suitable for treatment with the chemotherapy drugs nab-paclitaxel and gemcitabine.
    • Must have available tumor tissue for testing, either from a recent biopsy or a previous sample taken within 90 days before starting the study drug. If a biopsy is not possible and no suitable sample is available, participation is not allowed.
    • Must have a performance status score of 0 or 1, indicating the ability to carry out daily activities with little or no assistance.

Who cannot join the trial?

15 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not fully recovered from a previous cancer treatment.
  • Patients with serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that need treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer in the past, except for certain types of skin cancer or cervical cancer that have been treated.
  • Patients who have had an organ transplant.
  • Patients who are taking certain medications that might interfere with the study treatment.
  • Patients who have a history of severe allergic reactions to similar drugs.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients with brain or spinal cord conditions that are not stable.
  • Patients who have had major surgery recently.
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Investigated drugs

  • TTX-030

    is an experimental medication being tested to see if it can help treat metastatic pancreatic adenocarcinoma. It is being studied to understand if it can improve the effectiveness of standard chemotherapy treatments.

  • Budigalimab

    is another experimental medication included in the trial. It is being tested in combination with TTX-030 and chemotherapy to see if it provides additional benefits in treating metastatic pancreatic adenocarcinoma.

  • Nab-paclitaxel

    is a chemotherapy drug used to treat various types of cancer, including pancreatic cancer. It works by stopping the growth of cancer cells.

  • Gemcitabine

    is a chemotherapy medication that is commonly used to treat pancreatic cancer. It helps to slow or stop the growth of cancer cells.

What is already known about the treatment

  • TTX-030

    TTX-030 is administered intravenously and is currently being studied in clinical trials for its potential use in treating metastatic pancreatic adenocarcinoma. It is being evaluated for its effectiveness and safety when combined with chemotherapy. The main therapeutic indication is for patients who have not previously been treated for this type of cancer. TTX-030 works by targeting specific proteins involved in cancer cell growth, aiming to enhance the immune system's ability to fight the cancer. It is classified as an immunotherapy agent.

  • Budigalimab

    Budigalimab is administered intravenously and is under investigation in clinical trials for its role in treating metastatic pancreatic adenocarcinoma. It is being tested in combination with TTX-030 and chemotherapy to assess its efficacy and safety. The primary therapeutic indication is for patients who have not received prior treatment for this cancer. Budigalimab functions by inhibiting certain immune checkpoints, potentially boosting the immune response against cancer cells. It belongs to the class of monoclonal antibodies.

Investigated diseases

Pancreatic adenocarcinoma metastatic – This is a type of cancer that begins in the tissues of the pancreas and has spread to other parts of the body. The pancreas is an organ located behind the stomach that helps with digestion and blood sugar regulation. In its metastatic form, the cancer cells have traveled through the bloodstream or lymphatic system to distant organs, such as the liver or lungs. The disease often progresses rapidly, as the cancer cells grow and form new tumors in other areas. Symptoms may include abdominal pain, weight loss, and jaundice. The progression of the disease can vary, but it typically involves increasing symptoms and complications as the cancer spreads.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508356-19-00Protocol codeTTX-030-003Estimated enrolment173 patientsSponsorTrishula Therapeutics Inc.

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