Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study of ZL-1218 with or without Pembrolizumab in Subjects with Advanced Solid Tumor Cancers to Find a Suitable Dose and to Test How Different Doses of these Medications can be Tolerated by the Body

This research study is for people who have advanced solid tumour cancers. It's investigating a new drug called ZL-1218. In some cases, ZL-1218 will be given alongside an existing cancer medicine called pembrolizumab. The main goal of this study is to work out the safest and most effective dose of these medications. Because this is the very first time these drugs are being given to people, doctors also want to carefully watch how participants' bodies react to them and if there are any side effects. By doing this, they hope to learn more about how ZL-1218 works, both on its own and with pembrolizumab, to help treat advanced cancers in the future. The study is open to adults of all genders.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Zai Lab (Shanghai) Co. Ltd.

Enrolment target

Start

28 Aug 2023

Advanced solid tumors

What is this study about?

This study is looking at a new medicine called ZL-1218 for people with advanced solid tumour cancers. These are cancers that started in organs like the breast, lung, or bowel, and have spread to other parts of the body. The new medicine, ZL-1218, is being tested sometimes on its own, and sometimes with another cancer drug you might have heard of, called pembrolizumab.

The main purpose of this study is to find the right dose of ZL-1218, both by itself and when combined with pembrolizumab. Because this is the first time these medicines are being given to people, it’s really important for the doctors to carefully check how the body reacts to them and what side effects might occur. We call this a 'First-in-Human' study. This information helps doctors decide on the safest and most effective amount of medicine for future studies.

By taking part, you would be helping researchers learn more about how these drugs work against advanced solid tumours. This knowledge is vital for developing new and better treatments for cancer patients in the future. It's an early stage of clinical research, which means the focus is on safety and finding the correct dosage.

Key takeaways

This study is testing a new medicine (ZL-1218) for advanced solid tumour cancers.
It's a 'First-in-Human' study, focusing on safety and finding the right dose.
Some participants will receive ZL-1218 alone, others with pembrolizumab.
Open to adults (18+) of all genders with advanced solid tumours.
Participation involves regular clinic visits, blood tests, and scans.
You can withdraw at any time without affecting your normal care.

Who may be eligible?

This study is open to adults aged 18 and over, regardless of whether you are male or female. You would need to have an advanced solid tumour cancer.

To be considered for the study, your medical team would need to review your full health history. They would check specific health conditions and discuss previous treatments you’ve had to make sure the study is a suitable and safe option for you.

Having an advanced solid tumour simply means your cancer started in a solid organ (like the lung or breast) and has spread to other areas of your body.

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 an advanced solid tumour cancer?
Are you able to attend regular hospital appointments for tests and treatment?
Would you be comfortable taking a new study medicine?
Are you able to understand and sign an informed consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, ZL-1218, potentially with pembrolizumab, as directed by the study doctors. You would need to attend regular clinic visits for physical examinations, blood tests, and other assessments like scans, to monitor your health and how the medicine is affecting your cancer. The doctors will also check for any side effects. The total duration of your participation would depend on how your body responds to the treatment and the study plan, but you will be given a clear schedule. After receiving the medication, there will likely be follow-up appointments to continue monitoring your health.

Potential risks and benefits

Taking part in any clinical study carries both potential benefits and potential risks. A potential benefit of this study is receiving a new medicine that could help treat your advanced cancer, although there's no guarantee it will work for everyone. Potential risks include experiencing side effects from the study drugs, which will be carefully monitored. You will be fully informed about these before you agree to take part. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 does 'advanced solid tumour' mean?

It means your cancer started in a solid organ like the breast, lung, or bowel, and has spread to other parts of your body. 'Advanced' means it's progressed.

What is a 'First-in-Human' study?

This means it's the very first time these specific medicines are being given to people. Doctors are carefully checking safety and finding the right dose.

Will I definitely get the new medicine?

If you join the study, you would receive the new medicine ZL-1218, possibly with pembrolizumab. The study is designed to test these drugs.

What are the main goals of this study?

The main goals are to find a safe and appropriate dose of ZL-1218 (with or without pembrolizumab) and to understand how people tolerate these new medications.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.