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Experimental cancer drug GEN1047 tested in humans – study halted early

NCT ID NCT05180474

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tested a new drug called GEN1047 in people with advanced solid tumors (breast, endometrial, ovarian, or lung cancer) who had no other treatment options. The goal was to check safety, side effects, and how the body processes the drug. The study was terminated early, but the data may still help understand the drug's potential.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

179 people

The number who actually took part.

Started

Dec 2021

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Criteria - Escalation Part: * Participant must have histologically or cytologically confirmed solid tumor(s) in any of the following selected indications for which there is no further available standard therapy likely to confer clinical benefit (or participant is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, NSCLC-SCC. * Participants with ovarian cancer must have documented progressive disease (PD) on or after last prior treatment and within 60 days of screening. * Must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) on the day of signing informed consent. * Must have either recurrence after, or progression on or lack of response to available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting. * Must have at least 1 measurable lesion per RECIST v1.1. The measurable lesion(s) must be outside the field of radiation therapy (RT) if there was prior treatment with RT. * Must have an Eastern Cooperative Oncology Group performance status (ECOGPS) score of 0 to 1 at Screening and on C1D1 pretreatment. * Should provide a tumor tissue sample during the Screening period and prior to C1D1. * Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy. Criteria - Expansion Part Stage 1, 1b and Stage 2: * Participants must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose. * Participant must have advanced (unresectable) or metastatic, histologically confirmed diagnosis (breast cancer, endometrial cancer, ovarian cancer. * Must be a female and at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of consent. * Must have at least 1 measurable lesion per RECIST v1.1 as assessed by local investigator. * Must have an ECOG- PS score of 0 to 1 at Screening and on Cycle 1 Day 1 (C1D1) pretreatment. * Must submit a tumor tissue sample during the Screening period and prior to C1D1. * Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy. Key Exclusion Criteria: * Significant cardiovascular impairment within 6 months of the first dose of trial drug. * Participant with new or progressive brain metastases or spinal cord compression. * Participant has been exposed to any prior therapy with a compound targeting CD3 and/or B7H4 or cell based therapies. * Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of non-infectious drug-, immune-, or radiation-related pneumonitis that required steroid. Note: Other protocol defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm endometrial cancer endometrium neoplasm non-small cell squamous lung carcinoma ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer, breast neoplasms Endometrial cancer, endometrial neoplasm Ovarian cancer, ovarian neoplasms Squamous non small cell lung cancer (NSCLC-SCC)

Contacts and locations

Locations

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, France

  • CHU de Besancon

    Besançon, 25030, France

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centro Oncologico Clara Campal

    Madrid, 28050, Spain

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Erasmus Medisch Centrum

    Rotterdam, 3015CE, Netherlands

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900, Italy

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital Ruber Internacional

    Madrid, 28034, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitary Fundacion Jimenez Diaz

    Madrid, 2815, Spain

  • Hôpital Cochin

    Paris, France

  • IEO Istituto Europeo di Oncologia

    Milan, 435, Italy

  • Institut Bergonié

    Bordeaux, France

  • Institut Claudius Regaud

    Toulouse, France

  • Institut Curie

    Paris, 75248, France

  • Institut Gustave Roussy

    Villejuif, 75005, France

  • Institut du Cancer de Montpellier

    Montpellier, 34298, France

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Med-Polonia Sp. z o.o

    Poznan, Poland

  • NEXT Oncology Madrid

    Madrid, Spain

  • Radboudumc

    Nijmegen, 6525GA, Netherlands

  • Rigshospitalet (Copenhagen University Hospital)

    Copenhagen, 2100, Denmark

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • St Bartholomews Hospital

    London, EC1A7BE, United Kingdom

  • The Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • UCLA Department of Medicine Hematology Oncology

    Los Angeles, California, 90024, United States

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • University College London Hospital

    London, NW1 2BU, United Kingdom

  • University Medical Center Groningen

    Groningen, 9713GZ, Netherlands

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Yale University - Yale Cancer Center

    New Haven, Connecticut, 06520-8028, United States

More trials for these conditions

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