RecruitingPHASE1INTERVENTIONAL

A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors

This research study is looking at a new medicine called OKN4395, both on its own and when given together with another cancer drug called pembrolizumab. It's for people with different types of solid tumours, including sarcomas, lung cancer, and head and neck cancers. The main aims are to find out if OKN4395 is safe, what side effects it might cause, and how well people can tolerate it. Researchers will also check how the body handles the drug and if it shows any signs of fighting the cancer. The study will happen in two stages and will involve about 166 people across the US, Australia, UK, and Europe.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Epkin

Enrolment target

166

Start

23 Jan 2025

Estimated completion

01 Sep 2028

Solid Tumours Sarcoma HNSCC Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma NSCLC Pancreatic Adenocarcinoma Colorectal Cancer (CRC)Myxofibrosarcoma (MFS)Solitary Fibrous Tumors Dedifferentiated Liposarcoma Undifferentiated Pleomorphic Sarcoma (UPS)

What is this study about?

This study is a ‘Phase 1’ trial, which means it’s one of the first times this new drug, OKN4395, is being tested in people. The main goals are to understand if it’s safe, how well people tolerate it (meaning what side effects they experience and how manageable they are), and how it behaves in the body. Researchers will also be looking for any early signs that it might be effective against cancer. The study will test OKN4395 on its own and in combination with an existing cancer treatment called pembrolizumab.

The study is divided into two parts. In Part 1a, a small number of people with various solid tumours will receive different doses of OKN4395, either alone or with pembrolizumab. The dose will be slowly increased in small groups of patients to find a safe and tolerable amount. In Part 1b, more people with specific types of cancer – such as certain sarcomas, pancreatic cancer, lung cancer, bowel cancer, and head and neck cancer – will receive OKN4395, again either on its own or with pembrolizumab. Some parts of the study will also look at how taking OKN4395 with or without food, or with medicines that affect stomach acid, changes how the drug works in the body.

Overall, around 166 people will take part in this study. It's being conducted across several countries, including the UK, US, Australia, and parts of Europe. This careful step-by-step approach is standard for new medicines, ensuring that safety is the top priority while gathering important information about how the drug works.

Key takeaways

New drug (OKN4395) tested for safety and tolerance.
For various solid tumours, alone or with pembrolizumab.
First-in-human (Phase 1) study.
About 166 participants globally, including the UK.
Careful monitoring for side effects and drug effects.
Looks at how food/stomach acid might affect the drug.

Who may be eligible?

To be considered for this study, you would need to have certain types of advanced solid tumours that have either spread or can’t be removed by surgery. For many of the specific cancer types in this study, you would generally need to have tried other standard treatments already, and these treatments are either no longer working, not suitable for you, or you’ve chosen not to have them.

For example, if you have certain types of sarcoma, you would have usually had up to three previous courses of treatment. Similarly, people with pancreatic cancer, lung cancer, bowel cancer, or head and neck cancer would also have limits on the number of previous treatments they’ve received. There are also specific details for each cancer type, such as whether previous immunotherapy (like pembrolizumab) was given, or what genetic features the cancer might have. You would also need to be generally well enough to take part in a clinical trial, as assessed by the research team.

Your study doctor will carefully review all your medical information to see if this study would be a suitable option for you based on these detailed criteria. It's important that your cancer is confirmed by a biopsy or cell sample. This study is open to both men and women, aged 18 and over.

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.

Do I have an advanced solid tumour that's been confirmed by a doctor?
Have I already tried standard treatments for my cancer, and they are no longer working or suitable?
Am I generally well enough to take part in a study?
Am I aged 18 years or older?

Answer every question to see your result.

What does participation involve?

If you take part, you will receive either the new drug OKN4395, or OKN4395 along with pembrolizumab. The treatment will be given in cycles lasting 21 days for as long as the treatment is helping, or until you experience side effects that make it difficult to continue. You will have regular visits to the hospital for checks, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. You might be asked to take the OKN4395 drug either with food or without, or with other specific medication, depending on the part of the study you are in. The study team will explain everything in detail, including how long each visit might take and what is involved in each assessment.

Potential risks and benefits

Taking part in a clinical trial might offer you access to a new drug that isn't yet widely available, which could potentially help your condition. However, it's also possible that the new drug may not help you, or it could cause side effects. As this is a new drug, not all side effects are known, but the research team will closely monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

Precision NextGen Oncology and Research Center
Verified postcode
Beverly Hills, United States· Recruiting
Sarcoma Oncology Center
Verified postcode
Santa Monica, United States· Recruiting
MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Chris O'Brien Lifehouse
Verified postcode
Sydney, Australia· Recruiting
Linear Clinical Research
Verified postcode
Perth, Australia· Recruiting
The Beatson
Verified postcode
Glasgow, United Kingdom· Recruiting
Leicester Royal Infirmary
Verified postcode
Leicester, United Kingdom· Recruiting
University College London Hospital
Verified postcode
London, United Kingdom· Recruiting
The Christie
Verified postcode
Manchester, United Kingdom· Recruiting
Churchill Hospital
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is a Phase 1 study?

A Phase 1 study is usually the first time a new drug is tested in people. The main goals are to understand if it's safe, how it behaves in the body, and what side effects it might have.

What types of cancer are included in this study?

This study is for people with various solid tumours, including certain types of sarcoma, pancreatic cancer, non-small cell lung cancer, colorectal cancer, and head and neck squamous cell carcinoma.

What is pembrolizumab?

Pembrolizumab is an existing cancer treatment, a type of immunotherapy, that helps your body's immune system fight cancer.

Will I receive the new drug OKN4395 alone, or with pembrolizumab?

Some participants will receive OKN4395 alone, while others will receive it in combination with pembrolizumab. This will depend on the specific part of the study and your cancer type.

Where is this study taking place?

This study is happening in several countries, including the UK, US, Australia, and countries within the European Union.

How to find out more

Epkin

clinicaltrials@owkin.com +33 787922617 Official trial record

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