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Study of SBP-101, Nab-Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer

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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 a type of cancer called Metastatic Pancreatic Ductal Adenocarcinoma, which is a form of pancreatic cancer that has spread to other parts of the body. The study is testing a new treatment combination to see if it can help patients live longer. The treatment involves a new drug called SBP-101, which is a small molecule that affects the metabolism of certain compounds in the body. This drug is being tested in combination with two other cancer medications, nab-paclitaxel and gemcitabine. Some participants will receive these medications along with SBP-101, while others will receive a placebo instead of SBP-101.

The purpose of the study is to compare the overall survival of patients who receive the combination of SBP-101, nab-paclitaxel, and gemcitabine with those who receive only nab-paclitaxel and gemcitabine. Participants will be randomly assigned to one of the two groups, and neither the participants nor the researchers will know who is receiving SBP-101 or the placebo. The study will involve regular visits to the clinic for treatment and monitoring, and participants will receive the medications through injections or infusions.

The study will continue for a period of time, during which the health and progress of the participants will be closely monitored. The main goal is to see if the addition of SBP-101 can improve the length of time patients live with this type of cancer. The study will also look at other factors, such as how long it takes for the cancer to progress and the overall response to the treatment. Participants will be asked to complete questionnaires about their quality of life during the study.

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

    Initial treatment phase

    Upon joining the study, the patient will begin treatment with a combination of medications. These include SBP-101, nab-paclitaxel, and gemcitabine. The treatment is designed for individuals with metastatic pancreatic ductal adenocarcinoma who have not received prior treatment for this condition.

    The medication SBP-101 is administered as a subcutaneous injection. Nab-paclitaxel is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. Similarly, gemcitabine is also administered as an intravenous infusion.

  2. Step 2

    Treatment schedule

    The treatment involves regular administration of the medications. The specific dosage and frequency will be determined by the healthcare provider based on the patient's condition and response to the treatment.

    The treatment is expected to continue for a specified duration, which will be communicated by the healthcare team. Regular monitoring and assessments will be conducted to evaluate the patient's response to the treatment.

  3. Step 3

    Monitoring and assessments

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

    Quality of life will also be evaluated using specific questionnaires designed to understand the patient's well-being and any side effects experienced during the treatment.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation will be conducted to determine the overall survival and progression-free survival of the patient. This involves assessing the time from the start of the treatment until any progression of the disease or death from any cause.

    The results of this evaluation will help in understanding the effectiveness of the treatment and its impact on the patient's health.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma. This means the cancer started in the pancreas and has spread to other parts of the body.
  • The patient should not have received any treatment for this type of cancer before. The cancer must have been diagnosed within the last 3 months, and the patient should be expected to receive standard treatment with two drugs called gemcitabine and nab-paclitaxel.
  • The patient should have a life expectancy of at least 3 months.
  • The patient must be an adult, aged 18 years or older, and can be either male or female.
  • Females who can have children must have a negative pregnancy test within 14 days before starting the study treatment and must use a reliable method of birth control. Male patients with partners who can have children should also use a highly effective birth control method during the study and for 6 months after the last dose of the study drug.
  • The patient must have adequate function of the bone marrow, liver, kidneys, and blood clotting.
  • The patient must have a QTc interval of 470 milliseconds or less for women and 450 milliseconds or less for men on an ECG (a test that checks the heart's electrical activity). The QTc interval is a measure of the time it takes for the heart to recharge between beats.
  • The patient must be willing and able to provide written consent to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that have spread to different parts of the body.
  • Patients who have had a different cancer treatment within the last 4 weeks.
  • Patients with serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver disease.
  • Patients with severe kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that needs treatment.
  • Patients who have a history of allergic reactions to the study drugs.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • Nab-Paclitaxel

    is a medication used in cancer treatment. It is a form of chemotherapy that helps to stop the growth of cancer cells by interfering with their ability to divide and multiply. In this trial, it is used to treat patients with metastatic pancreatic ductal adenocarcinoma.

  • Gemcitabine

    is another chemotherapy drug used in this study. It works by slowing or stopping the growth of cancer cells. It is often used in combination with other medications to enhance its effectiveness in treating pancreatic cancer.

  • SBP-101

    is an investigational drug being tested in this trial. It is being studied to see if it can improve the overall survival of patients with metastatic pancreatic ductal adenocarcinoma when used alongside nab-paclitaxel and gemcitabine.

What is already known about the treatment

  • Nab-Paclitaxel

    This medication is administered intravenously and is used in combination with other drugs for treating certain types of cancer, including metastatic pancreatic ductal adenocarcinoma. It is currently well-established in medical practice and literature as a chemotherapy agent. Nab-paclitaxel works by inhibiting cell division, which helps to stop the growth of cancer cells. It belongs to the pharmacological class of taxanes.

  • Gemcitabine

    Administered through an intravenous infusion, gemcitabine is used to treat various cancers, including metastatic pancreatic ductal adenocarcinoma. It is widely recognized in medical literature as an effective chemotherapy drug. Gemcitabine acts by interfering with DNA synthesis, thereby preventing cancer cells from multiplying. It is classified as an antimetabolite.

  • SBP-101

    This investigational drug is given intravenously and is currently being studied for its potential use in treating metastatic pancreatic ductal adenocarcinoma. It is not yet fully established in medical practice, as it is still under clinical investigation. SBP-101 is believed to work by targeting specific pathways in cancer cells, leading to cell death. It is being explored as a novel therapeutic agent in combination with other chemotherapy drugs.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas and has spread to other parts of the body. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which are responsible for transporting digestive enzymes. As the disease progresses, it can invade nearby tissues and organs, leading to further complications. The spread of cancer cells to distant organs, such as the liver or lungs, is a hallmark of its metastatic nature. Symptoms may include abdominal pain, weight loss, and jaundice, among others. The progression of the disease can vary, but it typically involves increasing severity of symptoms and further spread of cancer cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-514714-12-00Protocol codeCL-SBP-101-04Estimated enrolment547 patientsSponsorPanbela Therapeutics Inc.

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