Solid TumoursPhase 2NCT06619509
A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
A Phase 2 study testing Brigimadlin in people with Solid Tumours, run by Boehringer Ingelheim at 50 sites in 20 countries.
Trial summary
This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- Brigimadlin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 50 sitesin 20 countries
- Study dates
- 30 Dec 2024to 30 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
- Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
- Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of <1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
- Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
- Adequate organ function.
- Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial.
Who cannot join
- Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
- Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.
- Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
- Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
- Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed in writing between the investigator and the sponsor.
- Further exclusion criteria apply.
Trial locations and contacts
50 sites in 20 countries.
50 sites in 20 countries
United States13 sites
Precision NextGen Oncology
Beverly Hills, California, 90212
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224
Northwell Health
Lake Success, New York, 11042
University of Wisconsin
Madison, Wisconsin, 53792
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Yale Cancer Center
New Haven, Connecticut, 06511
Nebraska Cancer Specialists-Omaha-69066
Omaha, Nebraska, 68130
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, 84106
Sarcoma Oncology Center
Santa Monica, California, 90403
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63108
Japan7 sites
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Okayama University Hospital
Okayama, Okayama, 700-8558
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Spain5 sites
Hospital Universitario Miguel Servet
Aragon, 50009
Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Clínico de Santiago
Santiago de Compostela, 15706
United Kingdom3 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
University College Hospital
London, NW12PQ
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
Australia2 sites
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, 2031
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
Canada2 sites
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Germany2 sites
Helios Klinikum Berlin-Buch
Berlin, 13125
Universitätsklinikum Tübingen
Tübingen, 72076
Italy2 sites
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Istituto Oncologico Veneto IRCCS
Padova, 35128
Denmark1 site
Copenhagen University Hospital, Rigshospitalet
København Ø, 2100
About this study
Official title: A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours
This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that was being developed to treat cancer.
All participants take brigimadlin as tablets once every 3 weeks at the study site. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.
- Conditions
- Solid Tumours
- Being tested
- Brigimadlin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrigimadlinDrug
Also called BI 907828
Brigimadlin
| Study group | Role | What they receive |
|---|---|---|
| Brigimadlin | Experimental | Not described Receives: Drug: Brigimadlin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period
CTCAE=Common Terminology Criteria for Adverse Events
Measured: up to 9 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start30 Dec 2024
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619509
- Sponsor's protocol ID
- 1403-0032
- Other IDs
- 2024-514177-21-00, U1111-1305-3484
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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.mystudywindow.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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours
- ClinicalTrials.gov ID
- NCT06619509
- Acronym / sponsor ID
- 1403-0032
- Conditions
- Solid Tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that was being developed to treat cancer.
All participants take brigimadlin as tablets once every 3 weeks at the study site. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brigimadlin | Experimental | Drug: Brigimadlin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
- Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
- Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of <1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
- Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
- Adequate organ function.
Key exclusion criteria (7 listed)
- Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
- Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.
- Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
- Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrigimadlinAlso: BI 907828Brigimadlin | Drug | Brigimadlin |
Primary outcome
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period
Time frame: up to 9 years.
CTCAE=Common Terminology Criteria for Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.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.
Related trials for Solid Tumours
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brigimadlin in people with Solid Tumours, run by Boehringer Ingelheim at 50 sites in 20 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Japan, Spain, United Kingdom, Australia and 15 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 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period (time frame: up to 9 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.