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New pill shows promise against advanced cancers in early trial

NCT ID NCT03449381

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new cancer drug called brigimadlin (BI 907828) in 266 adults with advanced solid tumors that had spread or stopped responding to standard treatments. The goal was to find a safe dose and see if the drug could shrink tumors. Brigimadlin is an MDM2 inhibitor taken as a tablet, either once every 3 weeks or on two days every 4 weeks. Participants stayed in the study as long as they benefited and tolerated the treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brigimadlin (BI 907828)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early phase 1 trial, so the main goal is just to find a safe dose. It is too soon to know if brigimadlin will actually shrink tumors or improve survival, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

266 people

The number who actually took part.

Started

Jun 2018

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). * 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 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 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.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer gastric adenocarcinoma neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms

Contacts and locations

Locations

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Florida Cancer Specialists-Sarasota-61670

    Sarasota, Florida, 34232, United States

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Karolinska Comprehensive Cancer Center

    Stockholm, 171 76, Sweden

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

    Poznan, 60-693, Poland

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202, United States

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781, Poland

  • Rigshospitalet, København

    København Ø, 2100, Denmark

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Severance Hospital

    Seoul, 03722, South Korea

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075, Germany

  • Yale University School of Medicine

    New Haven, Connecticut, 06511, United States

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