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

Last updated: May 13, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

BI 907828

Clinical Study ID

NCT03449381
1403-0001
2017-003210-95
  • Ages > 18
  • All Genders

Study 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.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated, written informed consent form ICF in accordance withICH-GCP and local legislation prior to any trial-specific procedures, sampling, oranalyses.

  • 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 forwhom no proven treatments exist.

  • Patients with MDM2 amplified sarcomas who require first line treatment (for PhIb/dose expansion - Cohort 1 only).

  • Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteriato be considered eligible.

  • Phase Ia (dose escalation) only:

  • Patient has a tumor with either a known TP53 wild type status, or unknown TP53status, 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 anyline of therapy. If TP53 status is not available during screening, the patient maybe included with unknown TP53 status if a tissue sample is submitted for centrallaboratory assessment. If TP53 status cannot be evaluated, the patient may beincluded 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 blanderand ampulla of vater) or pancreatic solidPDAC tumors who have had at least oneprevious line of therapy for advanced/metastatic disease. If TP53 status cannot beevaluated 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 pharmacodynamicanalyses 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. Ifthese requirements cannot be met, then the patient may be allowed to enter the studyat Sponsor discretion, after agreement between the Investigator and Sponsor.

  • Further inclusion criteria apply

Exclusion

Exclusion Criteria:

  • 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 treatedbrain metastases may participate provided they are stable, without evidence ofprogression by imaging (using the identical imaging modality for each assessment,either MRI or computed tomography (CT) scan), for at least four weeks prior to thefirst dose of trial treatment, and any neurologic symptoms have returned tobaseline; have no evidence of new or enlarging brain metastases. Patients oncorticosteroids 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 12weeks 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 theskin or in situ carcinoma of uterine cervix, or other local tumors considered curedby local treatment.

  • Patients who must or wish to continue the intake of restricted medications or anydrug considered likely to interfere with the safe conduct of the trial.

  • Further exclusion criteria apply.

Study Design

Total Participants: 267
Treatment Group(s): 1
Primary Treatment: BI 907828
Phase: 1
Study Start date:
June 20, 2018
Estimated Completion Date:
August 18, 2025

Connect with a study center

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Rigshospitalet, København

    København Ø, 2100
    Denmark

    Site Not Available

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitätsklinikum Köln (AöR)

    Köln, 50937
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

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

    Poznan, 60-693
    Poland

    Site Not Available

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781
    Poland

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Vall d'Hebron-Barcelona-47683

    Barcelona, 08035
    Spain

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Karolinska Comprehensive Cancer Center

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specialists-Sarasota-61670

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

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