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Breast Cancer, Breast NeoplasmsPhase 1/2NCT05180474

GEN1047 for Solid Tumors - First in Human (FIH) Trial

A Phase 1/2 study testing GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells. in people with Breast Cancer, Breast Neoplasms and Endometrial Cancer, Endometrial Neoplasm, run by Genmab at 36 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: The side effects seen with GEN1047 What the body does with GEN1047 once it is administered What GEN1047 does to the body once it is administered How well GEN1047 works against solid tumors The estimated trial… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
36 sitesin 9 countries
Study dates
13 Dec 2021to 25 Mar 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

36 sites in 9 countries.

36 sites in 9 countries

France9 sites

  • CHU de Besancon

    Besançon, 25030

  • Institut Bergonié

    Bordeaux

  • Centre Léon Bérard

    Lyon, 69008

  • Institut du Cancer de Montpellier

    Montpellier, 34298

  • Institut Curie

    Paris, 75248

  • Hôpital Cochin

    Paris

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers

  • Institut Claudius Regaud

    Toulouse

  • Institut Gustave Roussy

    Villejuif, 75005

Other trials in France

Spain9 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital Clinic de Barcelona

    Barcelona

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Ruber Internacional

    Madrid, 28034

  • Centro Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitary Fundacion Jimenez Diaz

    Madrid, 2815

  • NEXT Oncology Madrid

    Madrid

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Valencia

    Valencia

Other trials in Spain

United States6 sites

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • UCLA Department of Medicine Hematology Oncology

    Los Angeles, California, 90024

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale University - Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Netherlands3 sites

  • University Medical Center Groningen

    Groningen, 9713GZ

  • Radboudumc

    Nijmegen, 6525GA

  • Erasmus Medisch Centrum

    Rotterdam, 3015CE

Other trials in Netherlands

United Kingdom3 sites

  • St Bartholomews Hospital

    London, EC1A7BE

  • University College London Hospital

    London, NW1 2BU

  • The Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

Belgium2 sites

  • Antwerp University Hospital

    Edegem, 2650

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

Other trials in Belgium

Italy2 sites

  • IEO Istituto Europeo di Oncologia

    Milan, 435

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

Other trials in Italy

Denmark1 site

  • Rigshospitalet (Copenhagen University Hospital)

    Copenhagen, 2100

Other trials in Denmark

Poland1 site

  • Med-Polonia Sp. z o.o

    Poznan

Other trials in Poland

About this study

Official title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047:

  • The side effects seen with GEN1047
  • What the body does with GEN1047 once it is administered
  • What GEN1047 does to the body once it is administered
  • How well GEN1047 works against solid tumors

The estimated trial duration for an individual participant is 8 months, consisting of a 28-day screening period, an estimated 3 month treatment period (the duration of treatment may vary for each participant), and an estimated 4 month post-treatment follow-up period (the duration of follow-up may vary for each participant). All participants will receive active drug; no one will be given placebo.

Read the detailed description

The trial is an open-label, multi-center safety trial of GEN1047. The trial consists of two parts: a dose escalation part ("escalation" - phase 1) and an expansion part ("expansion" - phase 2a). The goal of the dose escalation part is to find out if GEN1047 is safe in participants with specific solid tumors and to find the best dose(s). In the expansion part of the trial up to two doses of GEN1047 will be tested.

Being tested
GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.
Medical subject headings
Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.Biological

    Also called DuoBody®-CD3-H101GxB7H4

    GEN1047 will be administered as an intravenous infusion. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.

Study groups in NCT05180474
Study groupRoleWhat they receive
GEN1047ExperimentalNot described
Receives: Biological: GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Escalation: Number of Participants with Dose Limiting Toxicities (DLT)

    DLTs will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0.

    Measured: From the first Cycle (Cycle length=21 days) in each cohort

  2. Escalation: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE is defined as an AE occurring or worsening between the first dose of study drug and 30 days after the last dose received.

    Measured: From first dose date up to end of the safety follow up period, 30 days after last dose (approximately 4 months)

  3. Expansion: Objective Response Rate (ORR)

    ORR is defined as percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1.

    Measured: Up to 5 years

Secondary outcomes (16)

  1. Escalation: Clearance

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  2. Escalation: Volume of Distribution (Vd)

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  3. Escalation: Area Under the Concentration-time Curve from Time 0 to Time of Last Dose (AUClast)

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  4. Escalation: AUC From Time Zero to Infinity (AUC0-inf)

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  5. Escalation: Maximum (Peak) Plasma Concentration (Cmax)

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  6. Escalation: Time to Reach Cmax (Tmax)

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  7. Escalation: Plasma Trough (Pre-dose) Concentrations (Ctrough)

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  8. Escalation: Elimination half-life (t 1/2)

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days)

  9. Escalation and Expansion: Number of Participants with Anti-Drug Antibody (ADA)

    Measured: Up to 5 years

  10. Escalation: ORR

    ORR is defined as percentage of participants with BOR of confirmed CR or confirmed PR based on RECIST v1.1.

    Measured: Up to 5 years

  11. Escalation and Expansion: Duration of Response (DOR)

    DOR is defined as the time from the first documented response to the first documented progression or death due to any cause.

    Measured: Up to 5 years

  12. Escalation and Expansion: Time to response (TTR)

    Time to response (TTR) is defined as the time from the date of Cycle 1 Day 1 (C1D1) to the first documented response of either confirmed CR or confirmed PR.

    Measured: Up to 5 years

  13. Escalation and Expansion: Disease control rate (DCR)

    The disease control rate (DCR) is defined as the percentage of participants with BOR of confirmed CR, confirmed PR, or stable disease (SD) according to RECIST v1.1

    Measured: Up to 5 years

  14. Expansion: Progression Free Survival (PFS)

    PFS is defined as the time from the date of C1D1 to the date of the first documented progression or death due to any cause, whichever occurs earlier according to RECIST v1.1.

    Measured: Up to 5 years

  15. Expansion: Overall Survival (OS)

    OS is defined as the time from date of C1D1 to date of death due to any cause.

    Measured: Up to 5 years

  16. Expansion: Number of Participants with TEAEs

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE is defined as an AE occurring or worsening between the first dose of study drug and 30 days after the last dose received.

    Measured: From first dose date up to end of the safety follow up period, 60 days after last dose (approximately 5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start13 Dec 2021
  3. Primary completion25 Mar 2026
  4. Study completion25 Mar 2026

Why it stopped: The Sponsor has made a strategic decision to stop the development of GEN1047.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180474
Sponsor's protocol ID
GCT1047-01
Other IDs
NL82658.056.23, 1007620, 2021-001790-23, 2024-510722-10, RECF-004736
Status last verified
Jul 2026
First submitted
8 Nov 2021
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells. in people with Breast Cancer, Breast Neoplasms and Endometrial Cancer, Endometrial Neoplasm, run by Genmab at 36 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France, Spain, United States, Netherlands, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The Sponsor has made a strategic decision to stop the development of GEN1047.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Escalation: Number of Participants with Dose Limiting Toxicities (DLT) (time frame: From the first Cycle (Cycle length=21 days) in each cohort). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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