Not recruiting

Safety Study of GEN1046 and Pembrolizumab in Patients with Malignant Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety of a new treatment for patients with malignant solid tumors. These tumors include types such as endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, and cervical cancer. The study involves two medications: KEYTRUDA and DuoBody®-PD-L1x4-1BB (also known as GEN1046). KEYTRUDA is a solution for infusion containing the active substance pembrolizumab, while DuoBody®-PD-L1x4-1BB is another solution for infusion with the active substance acasunlimab.

The purpose of this study is to determine the most suitable dose and to establish the safety profile of GEN1046. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will start with a dose-escalation phase, where different doses of the medication are tested to find the safest and most effective dose. After this, there will be an expansion phase to further evaluate the treatment's safety and effectiveness in a larger group of patients.

Throughout the study, researchers will monitor participants for any side effects and assess how well the treatment works against the tumors. The trial aims to provide valuable information on the potential benefits and risks of using GEN1046 in treating these types of cancer. The study is expected to continue until early 2026, allowing enough time to gather comprehensive data on the treatment's safety and effectiveness.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, participation begins with a thorough review of eligibility criteria. This includes having a confirmed diagnosis of a malignant solid tumor such as endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, or cervical cancer.
Eligibility also requires measurable disease and adequate function of blood, liver, and kidneys.
Step 2
Dose escalation phase
In this phase, the focus is on determining the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of the medication GEN1046.
The medication is administered as a solution for infusion through intravenous use. The specific dosage and frequency are adjusted based on individual tolerance and safety assessments.
Monitoring includes observing for dose-limiting toxicities and adverse events.
Step 3
Dose expansion phase
This phase aims to further evaluate the safety and effectiveness of GEN1046 at the determined dose.
Participants continue to receive the medication intravenously, with ongoing monitoring for adverse events and response to treatment.
The objective response rate, which measures the percentage of patients whose cancer shrinks or disappears after treatment, is assessed.
Step 4
Safety and efficacy evaluation
Throughout the trial, the safety profile of GEN1046 is closely monitored. This includes regular laboratory tests and assessments of any adverse events.
The clinical efficacy of the treatment is evaluated by measuring the duration of response, progression-free survival, and overall survival.
Step 5
Trial completion
The trial is estimated to conclude by January 30, 2026. At this point, all data collected will be analyzed to determine the overall safety and effectiveness of GEN1046 for treating malignant solid tumors.

Who can join the trial?

8 criteria

Patients must have a type of cancer called a malignant solid tumor. This includes endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, or cervical cancer.
For the first part of the study (Dose Escalation), patients must have a measurable disease, which means the cancer can be measured by doctors using tests or scans.
Patients need to have good enough blood, liver, and kidney function, as defined by the study's rules.
Patients must have a confirmed diagnosis of a non-CNS solid tumor that is metastatic (cancer that has spread to other parts of the body) or unresectable (cannot be removed by surgery), and there is no standard treatment available for them.
For the second part of the study (Dose Expansion), patients must have a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic non-small cell lung cancer (NSCLC), endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, or cervical cancer.
Patients should no longer be candidates for standard therapy or have refused it, if they had access and were eligible for those treatments.
Both male and female patients can participate in the study.
The study includes patients from vulnerable populations, which means people who might need extra protection or care.

Who cannot join the trial?

8 criteria

Patients with other types of cancer not listed in the study, such as those with cancers other than endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, or cervical cancer, cannot participate.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to provide informed consent, which means they cannot understand the study and agree to participate, cannot be included.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients with certain medical conditions or who are taking medications that might interfere with the study treatment cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to join this study.
Patients with a history of severe allergic reactions to similar treatments cannot participate.
Patients with uncontrolled medical conditions, meaning their health issues are not well-managed, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Unita Sanitaria Locale Della Romagna
Verified
Faenza, Italy
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

GEN1046 is a new experimental medication being tested for the first time in humans. It is designed to treat people with malignant solid tumors, which are a type of cancer. The main goals of the trial are to find out the safest dose of GEN1046 that can be given to patients and to understand how well it works in treating these tumors. The trial will also look at any side effects that might occur when taking GEN1046.

What is already known about the treatment

GEN1046 – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating various malignant solid tumors, including endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, and cervical cancer. It is in the early stages of research, with ongoing studies to determine the maximum tolerated dose and establish a recommended dose for further trials. GEN1046 is designed to target specific pathways involved in tumor growth and survival, aiming to inhibit cancer cell proliferation. It falls under the category of investigational cancer therapies, with a focus on enhancing the immune system's ability to fight cancer.

Investigated diseases

Endometrial Carcinoma
This is a type of cancer that begins in the lining of the uterus, known as the endometrium. It often presents with abnormal vaginal bleeding, especially after menopause. As the disease progresses, it may cause pelvic pain or a mass in the pelvic area. The cancer can spread to other parts of the body if not managed.
Urothelial Carcinoma
This cancer originates in the urothelial cells lining the bladder and other parts of the urinary tract. It typically causes symptoms such as blood in the urine, frequent urination, and pain during urination. As it advances, it may invade deeper layers of the bladder wall and spread to nearby tissues or distant organs.
Triple-Negative Breast Cancer
This is a subtype of breast cancer that lacks estrogen, progesterone, and HER2 receptors. It tends to grow and spread more quickly than other types of breast cancer. Symptoms may include a lump in the breast, changes in breast shape, or skin dimpling. It is often diagnosed at a more advanced stage due to its aggressive nature.
Squamous Cell Carcinoma of the Head and Neck
This cancer arises from the squamous cells lining the moist surfaces inside the head and neck. It can affect areas such as the mouth, throat, and nose. Symptoms may include a persistent sore throat, difficulty swallowing, or a lump in the neck. The disease can spread to nearby lymph nodes and other parts of the body.
Cervical Cancer
This cancer develops in the cells of the cervix, the lower part of the uterus that connects to the vagina. It often progresses slowly and may not cause symptoms in the early stages. As it advances, symptoms can include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. The disease can spread to nearby tissues and organs if not detected early.