A Study of GEN1047 in Patients with Solid Tumors: First Time Use in Humans

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What is this study about?

This study focuses on patients with malignant solid tumors, including breast cancer, endometrial cancer, ovarian cancer, and squamous non-small-cell lung cancer. The research examines a new medication called GEN1047, which is given as a solution for infusion directly into the vein. This is the first time this medication is being tested in humans.

The main purpose of this research is to find the safest and most effective dose of GEN1047 for treating these types of cancer. The study is divided into two parts. In the first part, different doses of the medication will be tested to determine the most appropriate amount. In the second part, the chosen dose will be given to more patients to better understand how well it works against these types of cancer.

During the study, patients will receive GEN1047 through intravenous administration. The treatment will be given in cycles, and doctors will regularly monitor patients’ health and how their cancer responds to the treatment. They will track any side effects and measure how the medication moves through the body. Patients will undergo regular medical examinations and imaging tests to assess their response to the treatment.

1 Initial screening and assessment

You will undergo screening to confirm eligibility for the trial. This includes checking your tumor type and medical history.

A tumor tissue sample will be collected during the screening period.

Your previous CT scans from the period after your last treatment will be reviewed.

Your physical condition will be assessed using the ECOG scale (a measure of daily living abilities).

2 Treatment initiation

The trial medication GEN1047 will be given through an intravenous infusion (directly into your vein).

Your treatment will be organized in cycles, starting with Cycle 1 Day 1 (C1D1).

Before starting treatment, your physical condition will be reassessed to ensure it remains stable.

3 Monitoring during treatment

Regular assessments will check for any side effects or unwanted reactions to the medication.

Blood tests will be performed to monitor your safety and check how your body processes the medication.

Antibody tests will be conducted to check your immune response to the treatment.

Regular scans will measure how your tumor responds to treatment using standard measurement criteria (RECIST).

4 Response evaluation

Your tumor response will be regularly assessed through scans.

The time until your tumor responds to treatment will be measured.

The duration of your response to treatment will be tracked.

Your overall health status and survival will be monitored.

5 Long-term follow-up

Your progress will be monitored until October 2026 (estimated end of trial).

Regular assessments will continue to track your health status and tumor response.

Any long-term effects of the treatment will be documented.

Who Can Join the Study?

  • Must be a female aged 18 or older (or legal age of consent in the study location)
  • Must have a confirmed diagnosis of one of these cancers:
    Breast cancer
    Endometrial cancer (cancer of the uterus lining)
    Ovarian cancer
    Squamous non-small cell lung cancer (a type of lung cancer)
  • Cancer must be either:
    – Advanced (cannot be surgically removed)
    – Or metastatic (has spread to other parts of the body)
  • Must have at least one measurable tumor that can be seen on scans
  • Must have progressive disease (cancer that has grown or spread) after previous treatment, shown on scans within the last 28 days
  • Must have an ECOG performance status of 0-1 (able to perform daily activities with minimal assistance)
  • Must be willing to provide a tumor tissue sample during the screening period
  • Must provide all previous CT scans that show how the cancer responded to last treatment
  • Either:
    – Previous standard treatments did not work
    – Or cancer returned after standard treatments
    – Or unable to tolerate standard treatments

Who Cannot Join the Study?

  • Previous participation in this clinical trial or current participation in other clinical studies
  • History of malignant tumors other than the one being studied in this trial
  • Presence of active or untreated brain metastases (cancer that has spread to the brain)
  • Pregnancy or breastfeeding
  • Serious heart conditions, including uncontrolled high blood pressure or recent heart attack
  • Severe liver or kidney dysfunction
  • Active, uncontrolled infections
  • Major surgery within 4 weeks before starting the study
  • Known allergic reactions to similar medications
  • Use of other experimental drugs within 4 weeks before starting this study
  • Psychiatric conditions that could interfere with study participation
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to understand or sign the informed consent form
  • History of other medical conditions that might affect the study results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Hospital Universitario Hm Sanchinarro Madrid Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
MD Anderson Cancer Center Madrid Spain
Med Polonia Sp. z o.o. Poznan Poland
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Rigshospitalet Copenhagen Denmark
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Iaxiqjtp Rdjgibos Dh Cnrndr Dx Mnluixrnjom Montpellier France
Czksdw Ltot Bjdjbh Lyon France
Uacwhhwfkwsl Mocixxx Cabvlaf Gtaexyxsy Groningen The Netherlands
Sfkvsumvq Rqiutyt Ufplvnixat Mdrkbrl Cgtvdk Nijmegen The Netherlands
Bguiemuy Uexdennfgw Htdxhqdv Cgskaa Besançon France
Ecflujf Uhsijdetwgyh Mouxflo Cezxwpe Rrzgzigfn (sjcpoim Mbx Rotterdam The Netherlands
Abhenve Uugdd Salibooqg Lhhgog Df Bnhxfvx Bologna Italy
Utqyjfnghx Op Anpflwz Edegem Belgium
Hnzbmxeq Vcal dhyzlxly Barcelona Spain
Ikryixwx Cutxy Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
13.12.2021
Denmark Denmark
Not recruiting
13.12.2021
France France
Not recruiting
13.12.2021
Italy Italy
Not recruiting
13.12.2021
Poland Poland
Not recruiting
13.12.2021
Spain Spain
Not recruiting
13.12.2021
The Netherlands The Netherlands
Not recruiting
13.12.2021

Trial locations

Investigated drugs:

GEN1047 is an investigational medication being studied for the first time in humans. It is designed to treat patients with various types of solid tumors (cancerous growths). This is a new drug that is being tested to understand how safe it is for patients and to find the right dose that can be used in future studies. The medication is being evaluated to see if it can help fight different types of cancer while monitoring any side effects that may occur.

Investigated diseases:

Malignant Solid Tumors – A group of cancers that form solid masses of abnormal tissue growth in various parts of the body. These tumors develop when cells begin to grow uncontrollably and form a lump or mass in organs or tissues. Unlike liquid cancers such as leukemia, solid tumors can be found in many body parts including the lungs, breast, colon, and other organs. The tumors can grow in size over time and may spread to nearby tissues. They can also release cancer cells that travel through the blood or lymph system to other parts of the body.

Trial ID:
2024-510722-10-00
Protocol code:
GCT1047-01
NCT ID:
NCT05180474
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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