Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients not Previously Treated for Metastatic Pancreatic Adenocarcinoma

This research study is investigating new treatment options for people diagnosed with pancreatic cancer that has spread to other parts of the body and who haven't received prior treatment for this widespread cancer. It's a 'Phase 2' study, meaning it aims to find out if new drug combinations are safe and effective enough to be studied further. Patients in the study will receive either standard chemotherapy alone or chemotherapy combined with one or two new drugs called Budigalimab and TTX-030. The main goal is to see if these new combinations can help patients live longer without their cancer getting worse, and to understand any side effects. This research helps doctors learn how to best treat advanced pancreatic cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Trishula Therapeutics Inc.

Enrolment target

Start

27 May 2024

Pancreatic adenocarcinoma metastatic

What is this study about?

When pancreatic cancer spreads to other parts of the body, it's called metastatic pancreatic adenocarcinoma. Doctors are always looking for better ways to treat this condition to improve patients' lives and slow down the cancer.

This study is testing different treatment approaches for patients who are starting their first treatment for metastatic pancreatic cancer. There are three main groups in the study. One group will receive the standard chemotherapy treatment. The other two groups will receive this standard chemotherapy along with one or two new investigational drugs called Budigalimab and TTX-030. The aim is to see if adding these new drugs can make the treatment more effective than chemotherapy alone.

The main thing the doctors want to find out is how long patients live without their cancer growing or spreading further. This is called 'progression-free survival'. They will also look at how many patients see their tumours shrink, how long that effect lasts, and overall how long people live. Importantly, they will also carefully monitor any side effects to understand the safety of these new drug combinations. This type of study helps gather important information to decide if these new treatments could become standard care in the future.

Key takeaways

This study is for people with pancreatic cancer that has spread and who are starting their first treatment for it.
It compares standard chemotherapy with new drug combinations, including Budigalimab and TTX-030.
The main aim is to see if the new treatments can keep cancer from progressing for longer.
Safety and side effects of the new drugs are also being carefully monitored.
Participants will have regular medical check-ups, blood tests, and scans.
You can withdraw from the study at any time if you choose.

Who may be eligible?

This study is for adults aged 18 years and older. Both men and women can take part. To be eligible, you must have been diagnosed with pancreatic cancer that has spread to other parts of your body, and you must not have received any previous treatment specifically for this widespread cancer.

There might be other specific health requirements or conditions that would mean you can or cannot join the study, such as your general health, how well your organs are working, and if you have certain other medical conditions. These details would be thoroughly checked by the study doctors.

If you are interested in this study, the research team will review your medical history and conduct examinations to make sure it's safe and appropriate for you to participate.

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.

Are you 18 years old or older?
Do you have pancreatic cancer that has spread to other parts of your body?
Have you *not* had any treatment yet for your widespread pancreatic cancer?
Are you able to attend regular hospital visits and appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of three treatment groups by chance, like flipping a coin. You will receive your assigned treatment, which will involve taking new medicines specifically for the study. This will include regular visits to the clinic for medical check-ups, blood tests, and scans (like CT scans) to monitor your health and how your cancer is responding.

The research team will closely track how you are feeling, any side effects you might experience, and your cancer's progress. You will continue with the treatment and monitoring for as long as it is safe and beneficial for you, or until the study's planned duration for treatment. After treatment, there will likely be a follow-up period to continue monitoring your health over time. The total duration of your involvement could vary depending on your individual response to treatment.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that are not yet widely available, which might be more effective than standard care. Your health will also be closely monitored by a dedicated medical team. However, there are potential risks, as the new drugs might have side effects that are not fully known or could be more severe than those from standard treatments. There's also no guarantee that the new treatments will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
France
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Unverified
Italy
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Unverified
Czechia

Common questions

What is 'Phase 2' in a clinical trial?

Phase 2 means the study is looking to see if a new treatment is safe and effective enough to be studied in a larger group of people. It focuses on finding the right dose and understanding common side effects.

What does 'metastatic' mean for pancreatic cancer?

It means the cancer has spread from where it started in the pancreas to other parts of your body.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.

What are Budigalimab and TTX-030?

These are investigational drugs, meaning they are still being studied. They are not yet approved for general use but are being tested to see if they can help treat pancreatic cancer.

What if I don't respond well to the treatment?

Your medical team will closely monitor your health and cancer. If the treatment isn't helping or causes too many problems, they will discuss other options with you and you can leave the study.