All studies
Active not recruitingPHASE2INTERVENTIONAL

Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours

This research study is for people who have pancreatic cancer that has spread or is locally advanced. Doctors want to find out how safe and effective a new combination treatment is. This combination includes an experimental drug called AZD0171, another drug called durvalumab, and standard chemotherapy (gemcitabine and nab-paclitaxel). The study will look at how the body handles these drugs and if they can help shrink the cancer or stop it from growing. Participants will continue treatment until the cancer gets worse, they have side effects that are too difficult to manage, or they choose to stop.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
126
Start
10 Dec 2021
Estimated completion
30 Jun 2026

Results

Results from this study

Posted November 2025

Results have been published for this study.

Primary outcome
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs)
The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.
Full results on the registry

What is this study about?

This study is exploring a new way to treat pancreatic cancer that has either spread to other parts of the body (metastatic) or is locally advanced (has grown beyond its original location but hasn't spread widely). The main goal is to test a new combination of medicines. This combination includes a drug called AZD0171, along with durvalumab, and the standard chemotherapy drugs, gemcitabine and nab-paclitaxel. These standard drugs are already used for pancreatic cancer, but doctors want to see if adding AZD0171 and durvalumab makes the treatment more effective or safer.

Pancreatic cancer can be a challenging disease to treat, and researchers are always looking for better options. This study hopes to understand several things: how safe this new combination is, if it can help fight the cancer, and how the body processes these drugs. By studying these aspects, medical experts hope to improve future treatments for pancreatic cancer.

The study is in 'Phase II', which means it's one of the steps in developing new medicines. It has already passed earlier safety tests, and now researchers want to learn more about its effectiveness and side effects in a larger group of patients. If the results are promising, it could lead to further research and potentially new treatment choices for people with this type of cancer.

Key takeaways

  • This study is testing a new combination treatment for advanced pancreatic cancer.
  • It includes an experimental drug (AZD0171) plus durvalumab and chemotherapy.
  • The main aims are to check safety and if the treatment works against the cancer.
  • Participation involves regular hospital visits, treatments, and tests.
  • You can stop participating at any time if you wish.
  • This is an early-stage study (Phase II) exploring new treatment possibilities.

Who may be eligible?

To join this study, people generally need to be quite well and able to carry out their daily activities. You must have pancreatic cancer that has spread or is locally advanced, and your cancer needs to be clearly visible on scans so doctors can measure how it's responding to the treatment. Also, a sample of your tumour will be checked to make sure certain immune cells are present.

There are several reasons why someone might not be able to join. For example, if your cancer has spread to your brain or spinal cord and is causing symptoms, or if you have certain heart problems, you likely won't be able to participate. You also can't join if you've had certain serious blood clots or a major heart event recently.

Additionally, you can't have active serious infections like hepatitis, HIV, or tuberculosis, and your body's main organs (like your liver, kidneys, and bone marrow) need to be working properly. If you already have a known genetic change in your pancreatic cancer for which there's a standard and preferred treatment, you also won't be eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have locally advanced or metastatic pancreatic cancer?
  2. Am I generally well enough to go about my daily activities?
  3. Do my scans show measurable cancer?
  4. Are my major organs (heart, liver, kidneys, bone marrow) working normally?
  5. Have I avoided recent serious infections or heart events?
  6. Do I have a tumour sample that can be checked for specific immune cells?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of medicines: AZD0171, durvalumab, gemcitabine, and nab-paclitaxel. These will be given according to a specific schedule decided by the study doctors. You will have regular hospital visits for these treatments and check-ups.

During your time in the study, you'll have various assessments. This includes physical exams, blood tests to check your general health and how the drugs are working, and scans (like CT scans) to see how your cancer is responding. You will also need to provide tissue samples from your tumour if you haven't already. These tests are done to monitor your health, look for side effects, and see if the treatment is effective.

Treatment will continue for as long as it is helping to control your cancer and as long as you are not experiencing side effects that are too difficult to manage. You will also be followed up by the study team even after you stop treatment to monitor your health. The total duration of your participation, including follow-up, will depend on how you respond to the treatment.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new experimental treatment combination that isn't yet widely available, and it could potentially help control your cancer. However, there are also potential risks; you might experience side effects from any of the study drugs, some of which could be serious. The new drug combination might not work for you, or it might not work better than existing treatments. You have the right to withdraw from the study at any time and for any reason, without affecting your future medical care.

Locations (34)

  • Research Site
    Verified postcode
    La Jolla, United States
  • Research Site
    Verified postcode
    Los Angeles, United States
  • Research Site
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    Orange, United States
  • Research Site
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    Ventura, United States
  • Research Site
    Verified postcode
    Atlanta, United States
  • Research Site
    Verified postcode
    Coeur d'Alene, United States
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    Ann Arbor, United States
  • Research Site
    Verified postcode
    Grand Rapids, United States
  • Research Site
    Verified postcode
    Buffalo, United States
  • Research Site
    Verified postcode
    New York, United States
  • Research Site
    Verified postcode
    Portland, United States

Common questions

What is the main goal of this study?

The main goal is to find out how safe and effective a new combination of drugs (AZD0171, durvalumab, and standard chemotherapy) is for people with advanced pancreatic cancer.

What type of cancer is this study for?

This study is for people with pancreatic cancer that is locally advanced or has spread to other parts of the body (metastatic).

Will I receive new medications?

Yes, you will receive an experimental drug called AZD0171, along with durvalumab and standard chemotherapy drugs (gemcitabine and nab-paclitaxel).

How long will I be in the study?

You'll be in the study for as long as the treatment is helping you and you're not having serious side effects. There might also be a follow-up period after you stop treatment.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time and for any reason. Your decision will not affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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