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

Verified siteInvestigationalNo placebo
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What is this trial about?

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

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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

14 criteria

  • 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
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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.

What is already known about the treatment

GEN1047 - An investigational drug currently undergoing first-in-human clinical trials for the treatment of malignant solid tumors. The medication is being evaluated in a dose-escalation study to determine its maximum tolerated dose and safety profile, with planned expansion to assess its anti-tumor activity. While the specific method of administration is not detailed in the source data, this experimental therapy is being studied to establish its recommended Phase 2 dose and evaluate its therapeutic potential in cancer treatment. The drug represents a new investigational approach in oncology, though its precise molecular mechanism of action is not specified in the available clinical trial information.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-510722-10-00Protocol codeGCT1047-01Estimated enrolment296 patientsSponsorGenmab A/S

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