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Adult Soft Tissue SarcomaPhase 2EMPIRENCT06084689

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

A Phase 2 study testing Ezabenlimab + BI907828 in people with Adult Soft Tissue Sarcoma and Non Small Cell Lung Cancer, run by Institut Bergonié at 6 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ezabenlimab + BI907828
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
6 sitesFrance
Study dates
14 Jun 2024to 1 Jul 2024
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis:
  • For cohort A: soft-tissue sarcoma. As recommended by the French NCI, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).
  • For cohort B: non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)
  • Age ≥ 18 years,
  • Advanced/unresectable and/or metastatic disease,
  • Mature TLS positive status
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  • TP53-wild type status known (by molecular biology)
  • Cohort A: MDM2 status known at the time of inclusion
  • Cohort B: are eligible the following populations
  • NSCLC known PD-L1 tumor proportion score (TPS) < 50% AND naïve from treatment with ICI (immune checkpoint inhibitors)
  • NSCLC exposed to anti-PD1 or PD-L1 based therapy with clinical benefit (clinical benefit is defined as objective response or stable disease for at least 4 months)
  • TNBC exposed to anti-PD1 or PD-L1 based therapy with clinical benefit (clinical benefit is defined as objective response or stable disease for at least 4 months)
  • MSS-CCR naïve from treatment with ICI
  • Biliary tract cancer exposed to anti-PD1 or PD-L1 based therapy with clinical benefit (clinical benefit is defined as objective response or stable disease for at least 4 months)
  • Patients must have measurable disease (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as > 10 mm with spiral CT scan.,
  • Performance status 0-2
  • Life expectancy ≥ 8 weeks,
  • Adequate hematologic and end-organ function as defined per protocol
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade ≤ 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0),
  • Ability to comply with the study protocol, in the investigator's judgment
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study treatment. Serum or urine pregnancy test must be repeated within 72 hours prior to receiving the first dose of study medication,
  • Both women of childbearing potential and men must agree to use two medically acceptable methods of contraception throughout the treatment period
  • No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for: a. superficial/non-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in > 1 year,
  • Voluntarily signed and dated written informed consent prior to any study specific procedure,
  • Patients with a social security in compliance with the French law.

Who cannot join

  • Prior treatment with ezabenlimab and/or BI 907828,
  • Women who are pregnant or breast feeding,
  • Participation to a study involving a medical or therapeutic intervention in the last 30 days,
  • Previous enrolment in the present study,
  • Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
  • Inability to swallow,
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  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins,
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the ezabenlimab or BI 907828 formulation,
  • Symptomatic or actively progressing central nervous system (CNS) metastases.
  • History of leptomeningeal disease,
  • Primary CNS tumors with any of the following characteristics:
  • History of intracranial hemorrhage or spinal cord hemorrhage
  • Neurosurgical resection or brain biopsy to the primary brain tumor within 28 days of Cycle 1 Day 1
  • Any systemic anticancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of ezabenlimab combined with BI 907828,
  • Whole brain radiotherapy within 14 days prior to start of BI 754091 combined with BI 907828
  • Stereotactic radiosurgery within 7 days prior to start of ezabenlimab combined with BI 907828
  • Active bleeding, significant risk of haemorrhage (e.g. previous severe gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current bleeding disorder (e.g. haemophilia, von Willebrand disease)
  • History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
  • Incomplete recovery from any surgery prior to the start of ezabenlimab combined with BI 907828 that would interfere with the determination of safety or efficacy of ezabenlimab combined with BI 907828
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
  • Uncontrolled tumor-related pain.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
  • Active or history of autoimmune disease or immune deficiency,
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active tuberculosis
  • Severe infection within 4 weeks prior to initiation of ezabenlimab combined with BI 907828, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of ezabenlimab combined with BI 907828.
  • Prior allogeneic stem cell or solid organ transplantation
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of ezabenlimab combined with BI 907828, or anticipation of need for such a vaccine during treatment or within 6 months after the final dose ezabenlimab combined with BI 907828. Seasonal flu vaccines that do not contain a live virus are permitted,
  • Current treatment with anti-viral therapy for HBV
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of ezabenlimab combined with BI 907828
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of ezabenlimab combined with BI 907828, or anticipation of need for systemic immunosuppressive medication during ezabenlimab combined with BI 907828.
  • Patients with oral anticoagulation based on Vitamin K antagonist.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Georges François Leclerc

    Dijon

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Léon Bérard

    Lyon

  • CHRU Poitiers

    Poitiers

  • Centre Eugène Marquis

    Rennes

Other trials in France

About this study

Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.

Read the detailed description

This study is a phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.

Inclusions will proceed independently for 2 cohorts of patients with TP53 wild-type and TLS+ tumors (TLS: tertiary lymphoid strucutres), as follows:

  • Cohort A: soft-tissue sarcomas
  • Single-arm phase II trial
  • 2-stage optimal Simon's design (Simon, 1989)
  • Primary endpoint: is Disease Control Rate (DCR) within 24 weeks of treatment onset, as per RECIST v1.1.
  • Cohort B: Solid tumors [non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)]
  • Single-arm phase II trial
  • 2-stage optimal Simon's design (Simon, 1989)
  • Primary endpoint: is Disease Control Rate (DCR) within 24 weeks of treatment onset, as per RECIST v1.1.
Being tested
Ezabenlimab + BI907828
Keywords
Tertiary lymphoid structures
Medical subject headings
Sarcoma, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Biliary Tract Neoplasms, Tertiary Lymphoid Structures

What participants receive

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

  • Ezabenlimab + BI907828Drug

    A treatment cycle consists of 3 weeks. Both treatments will be administered on Day 1 of each cycle.

Study groups in NCT06084689
Study groupRoleWhat they receive
Cohort A: soft-tissue sarcomasExperimentalSoft-tissue sarcomas
Receives: Drug: Ezabenlimab + BI907828
Cohort B: Solid tumorsExperimentalSolid tumors [non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)]
Receives: Drug: Ezabenlimab + BI907828

What is being measured

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

  1. Disease control rate (DCR)

    Disease control rate (DCR), defined as the proportion of patients with disease control lasting for at least 24 weeks since treatment onset, will be reported.

    Measured: 6 months

Secondary outcomes (5)

  1. Objective response rate

    Objective response rate (ORR), defined as the proportion of patients with objective response will be assessed, based on centralized radiological review, within 24 weeks of treatment onset.

    Measured: 6 months

  2. Duration of response (DoR)

    Duration of response (DoR) defined as the time from documentation of tumor response (CR, Cru, PR, PRu) to disease progression (as per RECIST V1.1).

    Measured: 1 year

  3. Progression-free survival (PFS)

    Progression-free survival (PFS) defined as the time from the first day of treatment to the first documented disease progression (as per RECIST v1.1) or death (due to any cause), whichever occurs first.

    Measured: 1 year

  4. Overall survival

    Overall survival defined as the time from the first day of treatment to death (due to any cause).

    Measured: 1 year

  5. Safety and tolerability of the combination

    Occurence of adverse events (AEs) and Serious adverse events (SAEs)

    Measured: Throughout treatment period, an expected average of 6 months

Timeline

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

  1. First posted16 Oct 2023
  2. Study start14 Jun 2024
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Why it stopped: Discontinuation of molecule development

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
Parallel groups
Model description
2 single-arm phase II trials: * Cohort A: soft-tissue sarcomas * Cohort B: Solid tumors \[non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)\]
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06084689
Sponsor's protocol ID
IB 2023-02
Other IDs
2023-506823-28-00, 2023
Acronym
EMPIRE
Status last verified
Aug 2025
First submitted
10 Oct 2023
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ezabenlimab + BI907828 in people with Adult Soft Tissue Sarcoma and Non Small Cell Lung Cancer, run by Institut Bergonié at 6 sites in France.

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 26 inclusion and 33 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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?

Disease control rate (DCR) (time frame: 6 months). 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 NCT06084689.

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 2 Sep 2025.

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