AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Phase 1b/2 Trial of OMTX705, an Anti-Fibroblast Activation Protein Antibody-Drug Conjugate, in Combination with Carboplatin, Pemetrexed and Tislelizumab in Patients with Advanced/Metastatic Non-squamous Non-Small Cell Lung Cancer

This research study is investigating a new treatment approach for a type of advanced lung cancer where the cancer has spread in the body. The study combines a new experimental drug, OMTX705, with existing treatments: carboplatin and pemetrexed (types of chemotherapy), and tislelizumab (a modern immunotherapy drug). The main goals of the study are to understand how safe this new drug combination is and to find the best dose of OMTX705 to use. Researchers will also be looking at how well this treatment shrinks the cancer or stops it from growing. This study is for adults aged 18 and over who have this specific type of lung cancer.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Oncomatryx Biopharma S.L.

Enrolment target

Start

12 Dec 2025

Advanced/Metastatic Non-squamous Non-Small Cell Lung Cancer

What is this study about?

This study is looking into a new way to treat non-small cell lung cancer that has spread to other parts of the body. This is a common and serious form of lung cancer. The researchers want to see if combining a new drug, OMTX705, with treatments already often used for this type of cancer can be more effective. The standard treatments included are chemotherapy drugs called carboplatin and pemetrexed, and an immunotherapy drug called tislelizumab.

The study is divided into two main parts. The first part focuses on safety and finding the right dose of the new drug, OMTX705, when used with the other treatments. Researchers will carefully watch for any side effects and how patients react to the new combination. The second part of the study will then look at how well this drug combination works to shrink or control the cancer, using the safe dose found in the first part.

The overall aim is to find out if this new combination treatment could be a better option for future patients with this kind of advanced lung cancer. By understanding the safety profile and how effective it is, doctors can learn if it's a promising path for continued research and potentially, a new treatment option.

Key takeaways

This study is for a specific type of advanced lung cancer.
It combines a new experimental drug with standard chemotherapy and immunotherapy.
The main goals are to check safety, find the best dose, and see how well it works.
Participation involves receiving treatment and regular health checks.
You can stop participating at any time if you wish.
This is an early-stage study, so the long-term effects are still being learned.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or older. The study is open to both men and women.

The main requirement is that you have a specific type of advanced lung cancer called non-squamous non-small cell lung cancer, and that this cancer has spread to other parts of your body. Your doctor will be able to confirm if your cancer fits this description.

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?
Have you been diagnosed with non-squamous non-small cell lung cancer?
Has your cancer spread to other parts of your body (metastasised)?
Are you able to travel to the study site for regular appointments and treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a combination of treatments: the new drug OMTX705, along with carboplatin, pemetrexed, and tislelizumab. The exact number and timing of hospital visits will be explained by the study team, but throughout the study, doctors and nurses will regularly check your health.

This will involve various assessments such as blood tests, checking your vital signs (like blood pressure and temperature), and scans to see how your cancer is responding. The study team will closely monitor you for any side effects from the treatments. There will also be a follow-up period after your treatments finish, to continue monitoring your health. The total length of your participation will depend on your individual response to treatment and will be explained in detail.

Potential risks and benefits

Potential benefits of joining this study include receiving a new experimental treatment that might be more effective than existing options for your lung cancer. You would also be closely monitored by a specialist medical team. However, as with any new treatment, there are potential risks, including side effects from the drugs. These side effects can vary in nature and severity and will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is advanced non-small cell lung cancer?

This is a type of lung cancer where the cancer cells have grown or spread to other parts of your body.

What is OMTX705?

OMTX705 is a new experimental drug being tested in this study. It's designed to target specific cancer cells.

What are carboplatin and pemetrexed?

These are chemotherapy drugs, which are commonly used to treat cancer by killing fast-growing cells.

What is tislelizumab?

Tislelizumab is an immunotherapy drug that works by helping your body's own immune system fight the cancer.

Will I know if the treatment is working?

The study team will perform regular scans and tests to check how your cancer is responding to the treatment.