Study on the Safety and Anti-tumor Effects of GEN1042 Alone or with Pembrolizumab and Chemotherapy in Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on evaluating the safety and effectiveness of a new treatment called DuoBody®-CD40x4-1BB (also known as GEN1042) for patients with certain types of cancer. The study involves patients with advanced or metastatic forms of melanoma, Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC), and Colorectal Cancer (CRC). The treatment will be tested both on its own and in combination with another medication called pembrolizumab, with or without additional chemotherapy drugs such as fluorouracil, cisplatin, gemcitabine hydrochloride, carboplatin, pemetrexed disodium, and paclitaxel.

The purpose of the study is to determine the most suitable dose of GEN1042 and to assess its ability to fight tumors. The trial will begin with a phase where the dose is gradually increased to find the maximum amount that can be safely given to patients. This is known as the “dose-escalation” phase. After this, the study will expand to include more patients to further evaluate the treatment’s effectiveness against tumors. During the trial, some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the new treatment.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The trial will monitor the patients for any side effects and measure how well the treatment works in reducing or controlling the cancer. The study aims to provide valuable information on the potential benefits of GEN1042 for treating these types of cancers.

1 joining the trial

Upon joining the trial, the patient will be informed about the study’s purpose, which is to evaluate the safety and anti-tumor activity of a new treatment called GEN1042.

The trial involves patients with certain types of cancer, including melanoma, non-small cell lung cancer, head and neck cancer, pancreatic cancer, and colorectal cancer.

2 initial assessment

An initial assessment will be conducted to determine the patient’s eligibility based on specific criteria outlined in the study protocol.

This assessment may include medical history review, physical examination, and laboratory tests.

3 treatment phase

The treatment phase involves administering GEN1042 either alone or in combination with pembrolizumab and possibly other chemotherapy drugs.

The drugs are given through an intravenous infusion, which means they are delivered directly into the bloodstream.

The dosage and frequency of administration will be determined based on the study’s dose-escalation design, aiming to find the maximum tolerated dose.

4 monitoring and evaluation

Throughout the trial, the patient’s response to the treatment will be closely monitored.

This includes regular check-ups, imaging tests, and laboratory evaluations to assess the treatment’s effectiveness and any side effects.

The primary goal is to determine the treatment’s safety and its ability to reduce tumor size.

5 completion of treatment

Once the treatment phase is completed, a final evaluation will be conducted to assess the overall response to the therapy.

The study aims to measure outcomes such as the duration of response, disease control rate, and progression-free survival.

6 follow-up

After completing the treatment, follow-up visits may be scheduled to monitor the patient’s long-term health and any delayed effects of the treatment.

These visits are important to ensure the patient’s well-being and to gather additional data on the treatment’s long-term efficacy.

Who Can Join the Study?

Patients must have malignant solid tumors. This means they have a type of cancer that forms in solid organs or tissues.
The specific types of cancer include relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC), or Colorectal Cancer (CRC).
Patients can be treated with monotherapy. This means using one type of treatment.
Patients can also be treated with combination therapy. This means using more than one type of treatment together.
Participants must be adults, as the age range includes categories 3 and 4, which typically refer to adults.
Both male and female patients are eligible to participate.
The study does not include vulnerable populations. This means groups that might need special protection or care are not part of this study.

Who Cannot Join the Study?

Patients who have a different type of cancer than those specified in the study.
Patients who are not adults, as the study is for adults only.
Patients who are pregnant or breastfeeding.
Patients who have a serious infection that is not controlled.
Patients who have a history of severe allergic reactions to similar treatments.
Patients who have another serious medical condition that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have received certain treatments recently that could affect the study results.
Patients who have a history of drug or alcohol abuse that could interfere with the study.
Patients who have a mental health condition that could affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
MD Anderson Cancer Center	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Hm Nou Delfos	Barcelona	Spain
Rigshospitalet	Copenhagen	Denmark
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Idlrogej Cidvby Dgeebvgfmdevobcgm	L'hospitalet De Llobregat	Spain
Hgkful Hnuyxlon	Herlev	Denmark
Uovwqsrqugnuowrvfdoiu Wamcmiwwd Aow	Wuerzburg	Germany
Hwfvvheu Vacp djudqpfv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	28.06.2019
France	Not recruiting	28.06.2019
Germany	Not recruiting	28.06.2019
Italy	Not recruiting	28.06.2019
Spain	Not recruiting	28.06.2019

Trial locations

Investigated drugs:

GEN1042 is an investigational medication being studied for its potential to treat malignant solid tumors. It is being tested to determine the safest and most effective dose when used alone or in combination with other treatments. The trial aims to understand how well GEN1042 can help reduce or eliminate tumors in patients.

Pembrolizumab is a medication that helps the immune system fight cancer. It is often used in combination with other treatments to enhance its effectiveness. In this trial, pembrolizumab is being combined with GEN1042 to see if the combination can improve outcomes for patients with malignant solid tumors.

Chemotherapy refers to a group of cancer-fighting drugs that work by killing or slowing the growth of cancer cells. In this trial, chemotherapy may be used alongside GEN1042 and pembrolizumab to assess whether this combination can provide better results in treating malignant solid tumors.

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new or unusual growth or a change in an existing mole. As it progresses, melanoma can spread to other parts of the body, including the lymph nodes and internal organs. Early stages may be confined to the skin, but advanced stages involve deeper skin layers and other tissues.

Non-Small Cell Lung Cancer (NSCLC) – NSCLC is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can grow slowly or rapidly, depending on the subtype. As it progresses, NSCLC can invade nearby tissues and spread to other parts of the body, such as the brain and bones.

Head and Neck Squamous Cell Carcinoma (HNSCC) – HNSCC is a cancer that arises from the squamous cells lining the moist surfaces inside the head and neck. It often begins in areas such as the mouth, throat, or voice box. The disease can progress by invading nearby tissues and spreading to lymph nodes and other organs.

Pancreatic Ductal Adenocarcinoma (PDAC) – PDAC is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It is known for its aggressive nature and tendency to spread quickly to nearby organs and distant sites. As it progresses, PDAC can obstruct bile ducts and cause symptoms like jaundice and weight loss.

Colorectal Cancer (CRC) – CRC is a cancer that starts in the colon or rectum, often beginning as a benign polyp that can become cancerous over time. It can grow into the wall of the colon or rectum and spread to nearby lymph nodes and other organs. The progression of CRC can lead to symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort.

Trial ID:

2023-508526-10-00

Protocol code:

GCT1042-01

NCT ID:

NCT04083599

Trial Phase:

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

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Study on the Safety and Anti-tumor Effects of GEN1042 Alone or with Pembrolizumab and Chemotherapy in Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?