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NeoplasmsPhase 1NCT03449381

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)

A Phase 1 study testing BI 907828 in people with Neoplasms, run by Boehringer Ingelheim at 27 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
BI 907828
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
27 sitesin 11 countries
Study dates
20 Jun 2018to 13 Nov 2025
Phase
Phase 1
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

  • Provision of signed and dated, written informed consent form ICF in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
  • Pathologically documented, advanced solid tumors.
  • Patients fulfilling one or more of the following criteria:
  • Radiologically documented disease progression or relapse
  • Patients who are not eligible to receive standard of care treatments, and for whom no proven treatments exist.
  • Patients with MDM2 amplified sarcomas who require first line treatment (for Ph Ib/dose expansion - Cohort 1 only).
Show all 23Show fewer
  • Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteria to be considered eligible.
  • Phase Ia (dose escalation) only:
  • Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry.
  • Phase Ib (expansion phase) only:
  • Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any line of therapy. If TP53 status is not available during screening, the patient may be included with unknown TP53 status if a tissue sample is submitted for central laboratory assessment. If TP53 status cannot be evaluated, the patient may be included if agreed between the Investigator and Sponsor.
  • Cohort 2: TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract (including cholangiocarcinoma, intra- and extrahepatic biliary tree, gall blander and ampulla of vater) or pancreatic solidPDAC tumors who have had at least one previous line of therapy for advanced/metastatic disease. If TP53 status cannot be evaluated the patient may be included if agreed between the Investigator and Sponsor
  • Phase Ia (dose escalation) only:
  • Patient with either measurable or non-measurable disease.
  • Non-evaluable disease allowed.
  • Phase Ib (expansion phase) only:
  • At least one target lesion that can be accurately measured per RECIST v.1.1.
  • Phase Ia:
  • Patient must be willing to undergo blood sampling for PK, pharmacodynamic, biomarker, and PGx analyses.
  • Phase Ib:
  • Patient must be willing to undergo tumor biopsy sampling for pharmacodynamic analyses and blood sampling for PK, pharmacodynamics, and biomarker analyses.
  • Willingness to provide a fresh tumor tissue sample obtained after relapse/ progression during or after prior therapy. In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen, collected before screening within 12 months of enrollment, may be submitted. If these requirements cannot be met, then the patient may be allowed to enter the study at Sponsor discretion, after agreement between the Investigator and Sponsor.
  • Further inclusion criteria apply

Who cannot join

  • Previous administration of BI 907828 (brigimadlin) or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
  • Known TP53 mutant tumor.
  • Symptomatic metastases from non-brain tumors. Note: Patients with previously treated brain metastases may participate provided they are stable, without evidence of progression by imaging (using the identical imaging modality for each assessment, either MRI or computed tomography (CT) scan), for at least four weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline; have no evidence of new or enlarging brain metastases. Patients on corticosteroids must have a stable dose for at least 5 days prior to baseline MRI.
  • Patients with history of bleeding diathesis.
  • Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to start of study treatment, or planned within 12 months after screening (e.g. hip replacement).
  • Any other documented active or suspected malignancy or history of malignancy within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  • Further exclusion criteria apply.

Trial locations and contacts

27 sites in 11 countries.

27 sites in 11 countries

United States9 sites

  • START Midwest

    Grand Rapids, Michigan, 49546

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Florida Cancer Specialists-Sarasota-61670

    Sarasota, Florida, 34232

Other trials in United States

Germany4 sites

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Poland2 sites

  • MED POLONIA SP Z O O, Clinical Trials Department,Poznan

    Poznan, 60-693

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781

Other trials in Poland

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Denmark1 site

  • Rigshospitalet, København

    København Ø, 2100

Other trials in Denmark

Israel1 site

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Japan1 site

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

Other trials in Japan

South Korea1 site

  • Severance Hospital

    Seoul, 03722

Other trials in South Korea

Sweden1 site

  • Karolinska Comprehensive Cancer Center

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 (Brigimadlin) in Patients With Advanced or Metastatic Solid Tumors

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink.

In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks.

The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

Conditions
Neoplasms
Being tested
BI 907828
Medical subject headings
Neoplasms

What participants receive

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

  • BI 907828Drug

    Also called brigimadlin

    Film-coated tablet

Study groups in NCT03449381
Study groupRoleWhat they receive
Dose EscalationExperimentalNot described
Receives: Drug: BI 907828
Dose ExpansionExperimentalNot described
Receives: Drug: BI 907828

What is being measured

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

  1. Phase Ia- Maximum tolerated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycle

    Measured: Up to 28 days

  2. Phase Ib - Progression-free survival

    Measured: Up to 24 months

  3. Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)

    Measured: Up to 28 days

  4. Phase Ib - Number of patients with DLTs during the first treatment cycle

    Measured: Up to 28 days

Secondary outcomes (7)

  1. Phase Ia - Cmax: Maximum measured concentration of BI 907828 in plasma

    Measured: Up to 24 months

  2. Phase Ia - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity

    Measured: Up to 24 months

  3. Phase Ib - Objective response

    Measured: Up to 24 months

  4. Phase Ib - Overall survival

    Measured: Up to 24 months

  5. Phase Ib - Number of patients with Grade ≥3 treatment-related adverse events observed during the entire treatment period

    Measured: Up to 24 months

  6. Phase Ib - Cmax: Maximum measured concentration of BI 907828 in plasma

    Measured: Up to 24 months

  7. Phase Ib - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity

    Measured: Up to 24 months

Timeline

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

  1. First posted28 Feb 2018
  2. Study start20 Jun 2018
  3. Primary completion13 Nov 2025
  4. Study completion13 Nov 2025

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03449381
Sponsor's protocol ID
1403-0001
Other IDs
2017-003210-95, 2017
Status last verified
Mar 2026
First submitted
12 Feb 2018
Last updated
31 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

  • Gollner A, Rudolph D, Weyer-Czernilofsky U, Baumgartinger R, Jung P, Weinstabl H, Ramharter J, Grempler R, Quant J, Rinnenthal J, Perez Pitarch A, Golubovic B, Gerlach D, Bader G, Wetzel K, Otto S, Mandl C, Boehmelt G, McConnell DB, Kraut N, Sini P. Discovery and Characterization of Brigimadlin, a Novel and Highly Potent MDM2-p53 Antagonist Suitable for Intermittent Dose Schedules. Mol Cancer Ther. 2024 Dec 3;23(12):1689-1702. doi: 10.1158/1535-7163.MCT-23-0783.

    PubMed 39259562

  • LoRusso P, Yamamoto N, Patel MR, Laurie SA, Bauer TM, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder MM. The MDM2-p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced or Metastatic Solid Tumors: Results of a Phase Ia, First-in-Human, Dose-Escalation Study. Cancer Discov. 2023 Aug 4;13(8):1802-1813. doi: 10.1158/2159-8290.CD-23-0153.

    PubMed 37269344

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 907828 in people with Neoplasms, run by Boehringer Ingelheim at 27 sites in 11 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 23 inclusion and 8 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Germany, Spain, Belgium, Poland and 6 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase Ia- Maximum tolerated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycle (time frame: Up to 28 days). The study lists 4 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 NCT03449381, which also lists 2 linked publications.

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 31 Mar 2026.

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