AzTrials
AzTrials

Advanced Endometrial CancerPhase 2NCT06046274

GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer

A Phase 2 study testing Pembrolizumab and Acasunlimab in people with Advanced Endometrial Cancer, run by Genmab at 29 sites in 6 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Endometrial Cancer
What is being tested?
Pembrolizumab and Acasunlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
29 sitesin 6 countries
Study dates
1 Oct 2023to 1 Jun 2028
Phase
Phase 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a histologically confirmed diagnosis of advanced (unresectable, recurrent, and/or metastatic) endometrial carcinoma that is incurable and for which prior standard first-line treatment has failed.
  • Prior to Cycle 1 Day 1 (C1D1), documentation of tumor dMMR/MSI-H status must be available based on local testing.
  • Must have progressed on or after at least 1 (but no more than 2) prior line(s) of a systemic chemotherapy regimen for unresectable and/or metastatic endometrial cancer of which at least 1 regimen of platinum-based treatment unless participant is ineligible for or intolerant to platinum.
  • Cohort A only: Must be treatment naive for CPIs including PD-1 or PD-L1 inhibitors and other immune CPIs (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT).
  • Cohort B only: Must have received and progressed on or after prior treatment with a PD-1/PD-L1 inhibitor alone or in combination. Moreover, the participant's duration of CPI containing treatment and best overall response (BOR) is known, and participant has received a minimum of 2 cycles of CPI.

Who cannot join

  • Histological diagnosis of carcinosarcoma, malignant mixed Műllerian tumor, endometrial leiomyosarcoma, or endometrial stromal sarcomas.
  • Ongoing or active infection requiring intravenous treatment with anti-infective therapy, or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening.
  • Any prior treatment with any type of antitumor vaccine, or autologous cell immunotherapy.
  • Radiotherapy within 14 days prior to first dose of acasunlimab. Note: palliative radiotherapy will be allowed for local pain control under certain conditions.
  • Treatment with an anticancer agent, including investigational vaccines within 28 days before or 5 times t1/2, whichever is shorter, prior to the planned first dose of trial treatment or is currently enrolled in an interventional trial.
  • Prior treatment with live, attenuated vaccines within 30 days prior to initiation of trial treatment.
Show all 14Show fewer
  • Received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support within 4 weeks before the planned first dose of trial treatment.
  • Cohort A only: Prior exposure to immune CPIs other than anti-PD-1/anti-PD-L1 (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell receptors (eg, 4-1BB, OX40)
  • Cohort B only:
  • Known history of Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy treatment
  • Exposure to any of the following prior therapies/treatments within the specified timeframes:
  • Prior exposure to immune CPIs other than anti-PD-1/anti-PD-L1 (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell receptors (eg, 4-1BB, OX40)
  • PD-1/PD-L1 antibody within 28 days before the planned first dose of trial treatment
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

29 sites in 6 countries.

29 sites in 6 countries

South Korea8 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • National Cancer Center Korea

    Goyang-si

  • Pusan National University

    Pusan

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System|Division of Infectious Diseases

    Seoul

Other trials in South Korea

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • ICO Girona

    Girona

  • Clínica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Fundacion Jiménez Díaz

    Madrid

  • Clínica Universidad de Navarra

    Pamplona, 31008

Other trials in Spain

Italy5 sites

  • AOU Policlinico Sant'Orsola Malpighi IRCCS

    Bologna

  • IRCCS Istituto Europeo di Oncologia IEO

    Milan

  • Fondazione G. Pascale

    Naples

  • IRCCS Policlinico Universitario Agostino Gemelli

    Roma

  • Ospedale Mauriziano Umberto I

    Torino

Other trials in Italy

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hospital de Charleroi

    Charleroi

  • Universitair Ziekenhuis Ghent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Denmark3 sites

  • Aalborg University Hospital

    Aalborg, 9100

  • Rigshospitalet

    Copenhagen

  • Odense Universitetshospital

    Odense

Other trials in Denmark

United States2 sites

  • Rudgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

Other trials in United States

About this study

Official title: A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer

The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). The main questions the study aims to answer are:

  • How well acasunlimab in combination with pembrolizumab works against endometrial cancer
  • What are the potential side effects participants may experience when they are treated with acasunlimab in combination with pembrolizumab

Participants will receive both acasunlimab and pembrolizumab. All participants will receive active drug; no one will receive placebo. participants will participate in 1 of 2 cohorts. A participant will receive study treatment up to a maximum of 24 months. The study duration (including screening, treatment, and follow-up) for each participant will be about 39 months.

Read the detailed description

This is an open-label multicenter study in participants with advanced (unresectable and/or metastatic) endometrial cancer to evaluate the safety and clinical activity of acasunlimab (GEN1046) in combination with immunotherapy.

The trial consists of two cohorts:

  • Cohort A (cohort closed)
  • Cohort B

The study will enroll approximately 80 participants in Cohort A and B (approximately 40 participants in each cohort).

Being tested
Pembrolizumab, Acasunlimab

What participants receive

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

  • PembrolizumabBiological

    Pembrolizumab intravenous (IV) infusion

  • AcasunlimabBiological

    Also called GEN1046, DuoBody®-PD-L1x4-1BB

    Acasunlimab IV infusion

Study groups in NCT06046274
Study groupRoleWhat they receive
Cohort A: pembrolizumab + acasunlimabExperimentalPembrolizumab will be administered in combination with acasunlimab as second-line (2L) or third-line (3L) therapy for dMMR/MSI-H in checkpoint inhibitor (CPI) naïve participants.
Receives: Biological: Pembrolizumab; Biological: Acasunlimab
Cohort B: pembrolizumab + acasunlimabExperimentalPembrolizumab will be administered in combination with acasunlimab as 2L or 3L therapy for mismatch repair deficient/ microsatellite instability-high (dMMR/MSI-H) participants who had prior exposure to programmed cell death protein/ programmed death ligand 1 (PD-1/PD-L1) inhibitors.
Receives: Biological: Pembrolizumab; Biological: Acasunlimab

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with a confirmed response of partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

    Measured: Up to 4 years

Secondary outcomes (4)

  1. Duration of Response (DOR)

    DOR is defined for responders as the time from initial onset of response to first progression event, defined as radiographic progression or death as per RECIST v1.1.

    Measured: Up to 4 years

  2. Time to Response (TTR)

    TTR is defined as the time from first infusion of trial treatment to onset of response as per RECIST v1.1.

    Measured: Up to 4 years

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of participants with a confirmed response of PR or CR or stable disease (SD) according to RECIST v1.1.

    Measured: Up to 4 years

  4. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and as Per Severity

    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 as per CTCAE V5.0. 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 90 days after the study treatment

Timeline

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

  1. First posted21 Sep 2023
  2. Study start1 Oct 2023 (estimated)
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Why it stopped: Enrollment challenged by availability of other treatment options

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046274
Sponsor's protocol ID
GCT1046-05
Other IDs
2022-502453-33-00
Status last verified
Apr 2024
First submitted
14 Sep 2023
Last updated
30 Apr 2024
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 2 study testing Pembrolizumab and Acasunlimab in people with Advanced Endometrial Cancer, run by Genmab at 29 sites in 6 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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in South Korea, Spain, Italy, Belgium, Denmark and 1 more country. 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 phase mean?

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 withdrawn before enrolling participants, so there are no results.

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?

Objective Response Rate (ORR) (time frame: Up to 4 years). 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 NCT06046274.

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 30 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in