AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

This research study is looking into new treatment combinations for different advanced or spreading cancers, including lung, cervical, melanoma, liver, and ovarian cancers, as well as head and neck cancer. We're testing two main combinations: DB-1311 with BNT327, or DB-1311 with DB-1305. The study has two parts. The first part focuses on finding the right dose and understanding any side effects. The second part will then look at how well the treatments shrink tumours and continue to monitor safety. The goal is to see if these new medicine combinations can be a safe and effective option for people living with these cancers.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Dualitybio Inc.

Enrolment target

102

Start

12 May 2026

Non-small cell lung cancer (NSCLC), Cervical cancer (CC), Melanoma, Hepatocellular carcinoma (HCC), Ovarian cancer (OC), Squamous cell carcinoma of head and neck

What is this study about?

This clinical trial is designed to investigate new treatment options for people who have advanced or metastatic solid tumours. These are cancers that have grown or spread to other parts of the body. The study includes several types of cancer: non-small cell lung cancer, cervical cancer, melanoma, liver cancer (hepatocellular carcinoma), ovarian cancer, and a type of head and neck cancer.

The main aim of this study is to see how safe and effective certain new drug combinations are. Specifically, we're looking at a medicine called DB-1311, which will be given with either BNT327 or DB-1305. This is a 'Phase II' study, which means that these medicines have likely been tested in earlier studies and are now being looked at in a larger group of people to get more detailed information about their effects.

The study is split into two main parts. The first part is about carefully figuring out the best dose of the new treatments and finding out about any side effects people might experience. Once that's clear, the second part will focus on how well the treatments work. We'll be checking if they can shrink tumours or stop them from growing, as well as continuing to keep a close eye on safety. This research is crucial for finding potentially better treatments for these difficult-to-treat cancers.

Key takeaways

New drug combinations are being tested for several advanced cancers.
The study aims to understand safety and tumour shrinking effects.
It involves regular hospital visits for treatments and checks.
Both potential benefits and risks of side effects exist.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part.

You would need to have one of the specific advanced or spreading cancers listed in the study, such as non-small cell lung cancer, cervical cancer, melanoma, liver cancer, ovarian cancer, or head and neck cancer.

There will be other detailed medical checks to make sure the study treatment is suitable and safe for you. These checks are important to protect your health and ensure the study can gather accurate information.

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 over?
Do you have advanced non-small cell lung, cervical, melanoma, liver, ovarian, or head and neck cancer?
Are you able to attend regular hospital appointments?
Are you willing to follow the study's treatment and assessment plan?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the study medication (DB-1311 along with either BNT327 or DB-1305), which will be given according to a specific schedule decided by the study doctors. You will undergo various assessments, such as physical examinations, blood tests, and scans, to monitor your health, check for any side effects, and see how the treatment is affecting your cancer. The total length of your participation will depend on how you respond to the treatment and the study plan, but there will also be a follow-up period after you stop treatment to monitor your health. The medical team will explain the full schedule to you.

Potential risks and benefits

There is a chance that taking part in this study could offer a benefit, such as your tumour shrinking or your disease being controlled for longer, especially if standard treatments haven't worked well for you. However, as with all medicines, there are potential risks, including side effects that could be mild, moderate, or serious. The study team will monitor you closely for any side effects. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Italy
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Unverified
Poland
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Unverified
France
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Unverified
Spain
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Unverified
Germany

Common questions

What types of cancer are being studied?

The study is for advanced non-small cell lung cancer, cervical cancer, melanoma, liver cancer, ovarian cancer, and a type of head and neck cancer.

What medicines are being tested?

We are testing DB-1311 in combination with either BNT327 or DB-1305.

What is the main goal of the study?

The main goals are to find out how safe these new treatments are and whether they can shrink tumours or stop them from growing.

How long will I be in the study if I join?

The length of your participation will depend on how you respond to the treatment and the study design, including a follow-up period after stopping treatment.

Can I leave the study at any time?

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