Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

First-In-Human, Open-Label, Dose Escalation Trial with Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy in Subjects with Malignant Solid Tumors.

This research study, called a clinical trial, is carefully looking at a new medicine called GEN1055. It's designed for people with different types of cancer (malignant solid tumours). The main goals are to understand if GEN1055 is safe, what side effects it might cause, and how well it helps treat cancer. Researchers are testing GEN1055 both by itself and in combination with other common cancer drugs, such as Pemetrexed, Pembrolizumab, Cisplatin, and Paclitaxel. This study is in its early stages (Phase I and Phase II), meaning it's among the first times this new medicine is being given to people. The information gathered will help doctors decide if GEN1055 could be a helpful new treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Genmab A/S

Enrolment target

Start

15 Mar 2024

Malignant Solid Tumors

What is this study about?

This study is a research project focusing on a new medicine called GEN1055 for people who have different types of cancer, often referred to as malignant solid tumours. Think of it as a careful step-by-step investigation. Initially, the study will give very small amounts of GEN1055 to a few people to make sure it's safe and to find the right dose. This is because it's a new medicine being given to humans for the first time.

As the study progresses, if GEN1055 appears safe, doctors will gradually increase the dose. They will also start testing it alongside other standard cancer treatments like Pemetrexed, Pembrolizumab, Cisplatin, and Paclitaxel. The main things the doctors are looking for are any side effects that happen and how severe they are. They will also carefully watch to see how the cancer responds to the treatment. This will help them understand if GEN1055 has the potential to shrink tumours or stop them from growing.

The information gathered from this study is really important. It will help researchers understand if GEN1055 could be a safe and effective new option for treating various cancers in the future. It's a key step in developing new medicines to help patients.

Key takeaways

Tests a new cancer medicine called GEN1055.
Aims to check safety and how well it treats various solid tumours.
GEN1055 is given alone or with other standard cancer drugs.
Open to adults aged 18 and older, both men and women.
This is an early-stage study, meaning it's among the first times in humans.

Who may be eligible?

To be able to join this study, participants generally need to be at least 18 years old. There's no upper age limit mentioned, meaning older adults could also be considered.

The study is open to both men and women.

Beyond age and gender, specific medical conditions and previous treatments will also be important. For example, participants would need to have specific types of cancer that meet the study's requirements. Your doctor will carefully review your medical history and current health to determine if this study is suitable for you.

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 a type of solid tumour (cancer)?
Are you able to attend regular hospital appointments?
Are you comfortable potentially trying a new, experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, GEN1055, and potentially other standard cancer treatments. This would involve regular visits to the hospital or clinic for blood tests, physical examinations, and scans to monitor your health and see how your cancer is responding. The number of visits and tests will depend on the phase of the study and how long you are on treatment.

You would be carefully monitored for any side effects throughout the study. The total duration of your participation would vary. Initially, it involves finding the safest dose, and then for those who continue, it would involve ongoing treatment and monitoring. This could potentially last for several months or longer, depending on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial like this offers the chance to access a new medicine before it's widely available. There's a possibility that GEN1055, either alone or with other treatments, could help slow down, stop, or even shrink your cancer. However, as with any medicine, there are potential risks, including side effects that could range from mild to serious. These 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 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 is GEN1055?

GEN1055 is a new medicine being studied to treat various types of cancer. It's still in the research phase.

What kinds of cancer is this study for?

This study is for people with different types of 'malignant solid tumours,' which means various solid cancers.

Will I get GEN1055 by itself or with other medicines?

GEN1055 will be tested both on its own and in combination with other common cancer treatments like Pemetrexed, Pembrolizumab, and Paclitaxel.

What are the main goals of this study?

The main goals are to see if GEN1055 is safe, what side effects it causes, and how well it works against cancer.

How long would I be in the study?

The length of time you'd participate can vary, depending on the study phase and how you respond to the treatment.