Study on the Safety and Effectiveness of GEN1078 for Patients with Malignant Solid Tumors

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a new treatment called GEN1078 for people with malignant solid tumors. Malignant solid tumors are a type of cancer that forms in solid organs or tissues, such as the lungs, liver, or pancreas. The treatment being tested, GEN1078, is given as a solution for injection under the skin, known as a subcutaneous injection.

The purpose of this study is to find the best dose of GEN1078 that can be safely given to patients and to see how well it works against the tumors. The study will start by giving small doses of GEN1078 to participants and gradually increasing the dose to find the maximum amount that can be tolerated without causing severe side effects. This part of the study is called dose escalation. After finding the right dose, more participants will receive this dose to further evaluate its safety and how well it works in shrinking or controlling the tumors. This is known as the dose expansion phase.

Throughout the study, researchers will closely monitor participants for any side effects and measure how the tumors respond to the treatment. The study aims to gather important information about the treatment’s safety and its potential to help people with malignant solid tumors. The trial is expected to continue until 2027, providing valuable insights into the use of GEN1078 for treating these types of cancers.

1 joining the trial

Upon joining the trial, participants will be informed about the study’s purpose, which is to evaluate the safety and effectiveness of a new medication called GEN1078 for treating malignant solid tumors.

Participants will be required to have at least one measurable tumor and a performance status score of 0 to 1, which indicates the ability to carry out daily activities with minimal assistance.

2 initial assessment

An initial assessment will be conducted to confirm the diagnosis of a solid tumor and to ensure that there are no further standard therapies available that are likely to provide clinical benefit.

This assessment will include a review of medical history and any previous treatments received.

3 dose escalation phase

During the dose escalation phase, participants will receive GEN1078 through a subcutaneous injection, which means the medication is injected under the skin.

The goal is to determine the maximum tolerated dose or the most appropriate dose for further study. Participants will be closely monitored for any side effects or adverse reactions.

4 dose expansion phase

In the dose expansion phase, the focus will be on assessing the anti-tumor activity of GEN1078 at the determined dose.

Participants will continue to receive the medication and will be monitored for any changes in their condition, including tumor response.

5 monitoring and follow-up

Throughout the trial, participants will have regular check-ups to monitor their health and the effects of the medication.

These check-ups will include physical exams, blood tests, and imaging studies to assess the size and progression of the tumor.

6 end of trial

The trial is expected to conclude by October 2027. At the end of the trial, participants will have a final assessment to evaluate the overall impact of the treatment.

Participants will be informed about the results of the trial and any potential next steps in their treatment plan.

Who Can Join the Study?

Must have at least one measurable lesion, which is a tumor that can be measured, as determined by the investigator using a specific guideline called RECIST v1.1.
Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
For the Dose Escalation part of the study: Must have a solid tumor confirmed by tests, for which there is no standard treatment available that is likely to help, or the patient is not a candidate for such treatment, or has refused it. The investigator believes that the experimental treatment with GEN1078 might be beneficial.
For the Dose Escalation part of the study: Must have had a return of the cancer or worsening of the disease after receiving standard treatments, or cannot tolerate or are not eligible for standard treatments that aim to cure the cancer in the recurrent setting.
For the Expansion part of the study: Must have advanced cancer that cannot be removed by surgery or has spread to other parts of the body, confirmed by tests.
Both male and female participants are eligible.
Participants from vulnerable populations are eligible.

Who Cannot Join the Study?

Patients with certain types of cancer called malignant solid tumors cannot participate. These are cancerous growths that form in solid organs or tissues.
Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Participants who are not able to follow the study procedures or who have conditions that might interfere with the study results are not eligible.
People who are part of a vulnerable population, which means they might need special protection or care, are not allowed to join the study.
Both males and females can participate, but there might be specific criteria related to gender that could exclude someone.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Rigshospitalet	Copenhagen	Denmark
Hpgsozzs Vcdd dnqowpxy	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.02.2025
Spain	Not recruiting	01.02.2025

Trial locations

Investigated drugs:

GEN1078

GEN1078 is a new medication being tested in this clinical trial. It is designed to help treat people with malignant solid tumors, which are a type of cancer. The trial is trying to find out how safe GEN1078 is for patients and how well it works against tumors. The researchers are also trying to figure out the best amount of GEN1078 to give to patients. This process involves starting with a small dose and gradually increasing it to see how much patients can tolerate without serious side effects. The ultimate goal is to see if GEN1078 can help shrink tumors or stop them from growing. This trial is an important step in understanding if GEN1078 could be a new option for cancer treatment in the future.

Malignant Solid Tumors – These are abnormal masses of tissue that arise from cells that grow uncontrollably and can invade nearby tissues. They can occur in various parts of the body, such as the lungs, breast, prostate, or colon. As they progress, these tumors can spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The growth and spread of these tumors can disrupt normal bodily functions and lead to various symptoms depending on their location. Malignant solid tumors are typically characterized by their ability to grow rapidly and invade surrounding tissues. The progression of these tumors can vary widely depending on the type and location of the tumor.

Trial ID:

2024-515752-21-00

Protocol code:

GCT1078-01

Trial Phase:

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

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Study on the Safety and Effectiveness of GEN1078 for Patients with Malignant Solid Tumors

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