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.

Start Date30 Dec 2024

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06370871

/ WithdrawnPhase 3

Brightline-3: A Phase III, Randomized, Open-label, Multi-center Trial of Brigimadlin + Ezabenlimab Compared to Gemcitabine + Docetaxel for Second-line Treatment of Patients With Advanced TP53 Wild-type Soft Tissue Sarcoma Subtypes

This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.
The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer.
Participants are put into 3 groups by chance:
* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks
* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks
* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma.
There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group.
Participants can continue treatment in the study as long as they benefit from it and can tolerate it.
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing.

Start Date27 Jun 2024

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06084689

/ WithdrawnPhase 2IIT

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

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.

Start Date14 Jun 2024

Sponsor / Collaborator

Institut Bergonié

[+1]

100 Clinical Results associated with Brigimadlin

100 Translational Medicine associated with Brigimadlin

100 Patents (Medical) associated with Brigimadlin

Literatures (Medical) associated with Brigimadlin

01 Jul 2026·Neural Regeneration Research

MDM2–GPX4–ferroptosis regulatory axis exerts neurotoxic effects in intracerebral hemorrhage

Article

Author: Song, Yuanmei ; Jiang, Rongcai ; Cao, Fang ; Cai, Yunpeng ; Liu, Tao ; Zhou, Hang ; Yu, Yunhu

Ferroptosis plays a key role in nerve injury in intracerebral hemorrhage and is associated with the upregulation of murine double minute 2. Investigating the mechanism underlying murine double minute 2-related ferroptosis could help identify new therapies for intracerebral hemorrhage. An in vitro intracerebral hemorrhage model was established by treating BV2 microglial cells with oxygen-glucose deprivation combined with hemin. The role of murine double minute 2 in regulating ferroptosis was investigated via transduction with RNA interference and lentivirus overexpression. Furthermore, intracerebral hemorrhage mouse models were constructed with and without an murine double minute 2 inhibitor (brigimadlin), and behavioral assays were performed to assess the learning ability and cognitive function. Murine double minute 2 dysregulation was associated with oxygen-glucose deprivation combined with hemin-induced BV2 microglial cell ferroptosis and M1/M2 polarization. The results suggested that murine double minute 2 induced glutathione peroxidase 4 ubiquitination and degradation to regulate ferroptosis and inflammatory responses in BV2 microglial cells. Mechanistically, Wilms tumor 1-associated protein induced murine double minute 2 N6-methyladenosine (m6A) modification and regulated ferroptosis and inflammatory responses. In vivo analysis showed that brigimadlin improved neurological deficits and spatial memory in mice with intracerebral hemorrhage. In summary, the results indicate that Wilms tumor 1-associated protein regulates murine double minute 2 m6A modification, and murine double minute 2 induces glutathione peroxidase 4 ubiquitination and degradation. This regulation promotes ferroptosis and inflammatory responses in oxygen-glucose deprivation combined with hemin-induced BV2 microglial cells, suggesting that the murine double minute 2-glutathione peroxidase 4-ferroptosis regulatory axis exerts neurotoxic effects. These findings identify glutathione peroxidase 4 as a potential gene therapy target for intracerebral hemorrhage-related brain injury.

12 Jan 2026·Neuro-oncology advances

Pharmacokinetic-pharmacodynamic-efficacy modeling of the MDM2 inhibitor brigimadlin in glioblastoma patient-derived xenografts

Article

Author: Decker, Paul A ; Kosel, Matt L ; Sarkaria, Nicole R ; Oh, Ju-Hee ; Hu, Zeng ; Sarkaria, Jann N ; Jain, Sonia ; Vaubel, Rachael A ; Talele, Surabhi ; Carlson, Brett L ; Sini, Patrizia ; Eckel-Passow, Jeanette E ; Mladek, Ann ; Bakken, Katrina K ; Elmquist, William F ; Burgenske, Danielle M ; Karbhari, Nishika ; Zhang, Wenjuan ; Ott, Lauren L ; Waller, Katie L ; Pasa, Tugce

Abstract:

Background:

Murine double minute 2 (MDM2) inhibitors reactivate wild-type p53 and are a promising therapy for glioblastoma, IDH-wildtype (GBM). Brigimadlin is a highly potent MDM2 inhibitor being tested in a phase 0/1 clinical trial in combination with radiation in GBM.

Methods:

Brigimadlin pharmacokinetics, pharmacodynamics, and efficacy were evaluated in GBM patient-derived xenografts (PDXs).

Results:

In vitro, brigimadlin impaired viability in TP53 wild-type GBM with an IC50 of 0.8-6.6 nmol/L, but sensitivity did not correlate with MDM2 amplification. In vivo, MDM2 amplification was highly correlated with efficacy. In subcutaneous PDXs, 1 or 2 mg/kg brigimadlin dosed weekly was highly effective in 2 MDM2-amplified PDXs. At 2 mg/kg, brigimadlin delayed tumor regrowth by >5-fold in the MDM2-amplified PDXs compared to 1.5-fold in a non-amplified PDX. In orthotopic PDXs, efficacy was more limited, but 2 mg/kg brigimadlin enhanced the response to fractionated radiation in MDM2-amplified PDXs. Consistent with blood-brain barrier efflux limiting drug distribution, 2 mg/kg brigimadlin extended survival by >5-fold in an MDM2-amplified orthotopic PDX established in Rag1−/−Abcb1a−/− Abcg2−/− mice. In pharmacodynamic studies, p53 target genes were upregulated at both subtherapeutic and therapeutic dose levels, and the extent of activation did not correlate with MDM2 status. Concentrations of brigimadlin in tumor tissue were approximately 10-fold higher in MDM2-amplified tumors, and intracellular drug levels directly correlated with drug-dependent MDM2 upregulation, suggesting target binding affects drug accumulation.

Conclusions:

Brigimadlin is highly effective in MDM2-amplified GBM when adequate drug levels are achieved in tumor tissue. MDM2 amplification impacts both treatment efficacy and intratumoral drug accumulation.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Brigimadlin (BI-907828) and napabucasin (BBI608) cooperatively trigger apoptosis in chronic lymphocytic leukemia cells by simultaneous inhibition of MDM2 and STAT3

Article

Author: Aptullahoglu, Erhan

BACKGROUND:

Chronic lymphocytic leukemia (CLL) remains largely incurable, particularly in elderly or treatment-resistant patients. Although MDM2 inhibitors restore p53-mediated apoptosis in p53-functional CLL, single-agent activity is limited by resistance mechanisms. Signal transducer and activator of transcription 3 (STAT3) signaling also promotes CLL survival and immune evasion, suggesting that concurrent blockade of both pathways may enhance cell death.

METHODS AND RESULTS:

Here, the synergistic potential of the oral MDM2 antagonist BI-907828 (brigimadlin) and the STAT3 inhibitor BBI608 (napabucasin) was evaluated in two CLL cell lines with distinct TP53 (Tumor Protein p53, the gene encoding p53 protein) status: p53-wild-type EHEB and p53-mutant/17p-deleted MEC-1. Monotherapy with BI-907828 induced marked p53 stabilization, upregulation of p21^WAF1, PARP cleavage, and caspase-3/7 activation in EHEB cells, whereas MEC-1 cells remained unresponsive. BBI608 alone reduced cell viability in both lines in a dose-dependent manner, with its effect in MEC-1 cells suggesting a p53-independent mechanism. When combined, BI-907828 and BBI608 synergistically enhanced apoptotic markers in EHEB cells (δ synergy score > 17) but elicited no synergy in MEC-1, underlining the requirement for intact p53.

CONCLUSION:

These findings establish a mechanistic rationale for the concurrent targeting of the MDM2 and STAT3 axes and provide preclinical evidence for a promising, non-genotoxic therapeutic strategy in p53-functional CLL. A limitation of this study is the lack of in vivo validation and clinical data, which are necessary to further assess the safety, optimal dosing, and efficacy, particularly in elderly or unfit patients with limited treatment options.

News (Medical) associated with Brigimadlin

14 May 2025

·firstwordpharma.com

Boehringer Ingelheim expands oncology pipeline with real-world data from Tempus AI

Boehringer Ingelheim has entered a multi-year partnership with Tempus AI to leverage its real-world data and AI platform in support of Boehringer's expanding oncology pipeline. Through the partnership, Boehringer will gain access to Tempus' de-identified data and its advanced data analytics platform, Lens."Leveraging real-world patient data is crucial for strengthening our data foundation and harnessing advanced AI methodologies, ultimately accelerating drug development," said Jan Nygaard Jensen, head of computational innovation at Boehringer Ingelheim. "Integrating these comprehensive datasets with our internal data and techniques not only drives innovation but also enhances the precision and efficiency of pharmaceutical research, paving the way for groundbreaking medical advancements."Tempus' database comprises over eight million research records. Its AI-enabled Lens platform allows researchers to define patient cohorts using molecular and clinical filters, or to automatically build cohorts using Tempus One, an AI-enabled assistant that applies inclusion and exclusion criteria. Researchers can visualise or download datasets for in-depth analysis. These insights can support biomarker discovery, patient stratification, novel target identification, hypotheses for combination therapies and patient education. Boehringer currently markets three oncology drugs — Gilotrif (afatinib) and Ofev (nintedanib) for non-small-cell-lung cancer (NSCLC) and Tevimbra (tislelizumab) for oesophageal and gastric cancers. Its oncology pipeline includes a broad portfolio of investigational agents, such as anti-DLL3 T-cell engager BI 764532 in phase II trials for small cell lung cancer and neuroendocrine cancers; HER2 exon 20 inhibitor zongertinib in phase III trials for NSCLC and MDM2-p53 antagonist brigimadlin in phase III trials for de-differentiated liposarcoma and soft tissue sarcoma, and phase II trials for NSCLC and bile duct cancer. Additional early-stage assets target a variety of solid tumours."By combining internal, pre-clinical experimental data, with real-world data from Tempus on its AI-powered platform, we can profoundly deepen our understanding of cancer biology and accelerate our drug discovery and development efforts," said Mark Paul Petronczki, head of oncology research at Boehringer Ingelheim.

Phase 2Phase 3ASCO

23 Apr 2025

·www.pharmaceutical-technology.com

Boehringer to expand oncology presence with $572m Tessellate Bio deal

Boehringer expands oncology pipeline with Tessellate deal. Credit: Sundry Photography via Getty Images. Boehringer Ingelheim has signed a €500m ($572m) agreement with UK-based biotech Tessellate Bio to co-develop targeted cancer therapies for tumours that rely on the alternative lengthening of telomeres (ALT) mechanism – a lesser-known telomere maintenance process that supports the survival of certain hard to treat cancers. Under the terms of the deal, Tessellate Bio will receive an upfront licensing fee, research funding, and technical milestone payments, along with additional success-based development and commercial milestones. The total potential value of the agreement is more than $572m. Tessellate has developed small molecule inhibitors against an undisclosed target that plays a central role in enabling the replication and survival of ALT-positive cancer cells. According to the company, preclinical data shows that blocking this target leads to DNA damage and replication stress, selectively killing tumour cells dependent on the ALT mechanism while sparing healthy cells that do not use this pathway. The collaboration builds on Tessellate’s ongoing work to characterise ALT activity across tumour types, following a research initiative launched in September 2024 with Australian research institutes CMRI and Omico. Tessellate secured €8m in seed funding from BioGeneration Ventures and Forbion when it launched publicly in October 2023. This deal with Boehringer marks Tessellate’s first partnership with a biopharma company. For Boehringer, this deal aligns with its strategic expansion in oncology. Over the last few years, the German pharma company has pursued a series of R&D and licensing agreements to strengthen its cancer portfolio. In October 2024, it partnered with Circle Pharma to co-develop a first-in-class cyclin inhibitor, in a deal worth up to $607m in upfront and milestone payments. That same month, it opened a €60m ($66.8m) research building in Vienna, Austria , focused on advancing novel cancer therapies. Boehringer’s marketed oncology products include Giotrif (afatinib) for EGFR-mutated non-small cell lung cancer (NSCLC) and Vargatef (nintedanib) for specific types of lung cancer. The company is also advancing late-stage assets such as brigimadlin, an MDM2-p53 antagonist in a pivotal clinical trial for rare cancer dedifferentiated liposarcoma (DDLPS). Boehringer is also advancing zongertinib , a tyrosine kinase inhibitor being evaluated as a potential treatment for HER2-mutated NSCLC. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence In January 2025, Boehringer signed two further licensing agreements to deepen its pipeline. The first, with Synaffix, grants access to the company’s antibody-drug conjugate (ADC) platform in a deal worth up to $1.3bn , covering multiple undisclosed targets. The second was an extension of a long-standing partnership with Oxford BioTherapeutics, under which Boehringer exercised an option for a fourth novel target. Oxford BioTherapeutics will receive development milestones and royalties, while Boehringer takes over full development and commercial responsibilities.

License out/inADC

27 Aug 2024

·www.prnewswire.com

Boehringer Ingelheim to unveil groundbreaking oncology research at WCLC, demonstrating strength of portfolio

RIDGEFIELD, Conn., Aug. 27, 2024 /PRNewswire/ -- Data from the Phase Ib Beamion LUNG-1 trial selected for late-breaking oral presentation in the Presidential Symposium at WCLC on Monday, September 9. The U.S. FDA and China's CDE have granted zongertinib Breakthrough Therapy Designation for patients with HER2-mutated NSCLC and who have received prior systemic therapy. Phase I trial data of a novel DLL3-targeting T-Cell Engager, which has already secured FDA Fast Track as well as FDA and EMA Orphan Drug Designations, will also be presented. At the IASLC 2024 World Conference on Lung Cancer (WCLC) Boehringer Ingelheim will present encouraging data from across its oncology pipeline, illustrating its aspiration to transform the lives of people with cancer by delivering meaningful advances. Carinne Brouillon, Head of Human Pharma at Boehringer said: "Every year, about 40,000 people worldwide are diagnosed with non-small cell lung cancer (NSCLC) with a HER2 mutation.i While targeted therapy is available for some cancers driven by HER2, people living with HER2-mutated NSCLC have few options. We are proud to be sharing new data evaluating our investigational zongertinib in this hard-to-treat setting. Our strong oncology pipeline underscores our strategic approach in advancing novel targeted treatments and cancer cell-directed therapies that have a potential to transform lives for generations of patients." Late-breaking results from the Beamion LUNG-1 trial, which is a Phase Ia/b trial evaluating the safety and efficacy of zongertinib (BI 1810631), a HER2-specific tyrosine kinase inhibitor (TKI), will be presented at WCLC. This includes new data from a primary analysis of the first Cohort of Phase Ib in pre-treated patients with HER2m+ NSCLC to be presented in a Presidential Symposium on Monday, September 9, from 8:30AM - 10:00AM PDT (Location: Plenary Hall) and featured in the official WCLC Press Program. Highlighting the potential of zongertinib, the investigational oral therapy was recently granted Breakthrough Therapy Designation by the U.S. FDA and China's CDE for the treatment of adult patients with advanced, unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, and who have received a prior systemic therapy. Investigating the potential of DLL3 targeted immunotherapy to transform the treatment of neuroendocrine carcinomas Exploring the promise of DLL3-targeted immunotherapy in transforming the treatment of neuroendocrine carcinomas, Boehringer will present data from the Phase I trial of its novel DLL3-targeting T-Cell Engager, BI 764532 in an Oral Presentation on Monday, September 9, from 2:22 PM-2:32 PM PDT (Location: 20A). This investigational treatment, which has been granted FDA Fast Track as well as FDA and EMA Orphan Drug Designations, is currently being evaluated in patients with large-cell neuroendocrine carcinoma of the lung (LCNEC-L), small cell lung cancer (SCLC) and extrapulmonary neuroendocrine cancer (epNEC). BI 764532 is designed to redirect T-cells to target tumors that express the DLL3 protein. In addition to the five abstracts to be presented at WCLC, Boehringer will also host a symposium titled "Emerging Therapies in Clinical Practice: What are the Patient Perspectives on the Future of Lung Cancer Treatment?" on Saturday, September 7, from 3:45PM to 4:45PM PDT (Location: 30DE). At Boehringer, cancer care is personal, which is why this event will explore patient viewpoints and expectations regarding the evolving landscape of lung cancer therapy. Data from Boehringer's oncology pipeline to be presented at WCLC: About non-small cell lung cancer (NSCLC) Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.ii NSCLC is the most common type of lung cancer.iii The condition is often diagnosed at a late stage,iv and fewer than 3 in 10 patients are alive five years after diagnosis.v People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives. There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Around 4.7% of lung cancers are driven by HER2 mutations (or gene alterations).i,vi About zongertinib Zongertinib (also known as BI 1810631) is an investigational oral HER2-specific tyrosine kinase inhibitor (TKI) that is highly selective and being developed as a potential treatment for non-small cell lung cancer (NSCLC). Zongertinib was granted FDA Fast Track Designation in 2023, then in 2024 it was granted Breakthrough Therapy Designation by the U.S. FDA and China CDE for the treatment of adult patients with advanced NSCLC whose tumors have activating HER2 mutations, and who have received a prior systemic therapy. HER2 is a member of the ErbB family of receptor tyrosine kinases (enzymes that act like chemical messengers). Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread. Read more here. About BI 764532 BI 764532 is an investigational DLL3/CD3 IgG-like T-Cell Engager under development as a potential new targeted immunotherapy for patients with large-cell neuroendocrine carcinoma of the lung (LCNEC-L), small cell lung cancer (SCLC) & extrapulmonary neuroendocrine cancer (epNEC). The therapy is designed to directly redirect T-cells, potentially resulting in the selective killing of tumor cells by the body's own immune system. Pre-clinical in-vivo data suggests administration of DLL3/CD3 bispecific T-cell engager (ITE) monotherapy induces T-cell infiltration into tumor tissues, transforming a non-inflamed (cold) tumor microenvironment into an inflamed (hot) state. This process triggers tumor cell apoptosis, resulting in significant tumor regression. BI 764532 has been granted FDA Fast Track as well as FDA and EMA Orphan Drug Designations. Read more here. About brigimadlin Brigimadlin (also known as BI 907828) is an investigational oral MDM2-p53 antagonist being developed as a potential treatment for certain types of cancer. The small molecule compound may inhibit the interaction between MDM2 and p53, restoring p53 wild type function. Inactivation of the tumor suppressor protein p53 is a central mechanism by which cancer cells drive tumor growth. Increased levels of the protein MDM2, a key negative regulator of p53, is a well-characterized inactivation mechanism, seen in about 5-7% of all cancer cases. About Boehringer Ingelheim in Oncology We have a clear aspiration – to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. Boehringer Ingelheim's generational commitment to driving scientific innovation is reflected by the company's robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as the smart combination of these approaches. Boehringer's ambition in oncology is to take a diligent and broad approach, creating a collaborative research network to tap into a diversity of minds, which is vital in addressing some of the most challenging, but potentially most impactful, areas of cancer research. Simply put, for Boehringer Ingelheim, cancer care is personal, today and for generations. Read more here. About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Lean more at boehringer-ingelheim.com/us. i Chia, P. et al. Prevalence and natural history of ALK positive non-small-cell lung cancer and the clinical impact of targeted therapy with ALK inhibitors. Clinical Epidemiology. . ii International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed August 2024). iii Zappa C & Mousa Non-small cell lung cancer: current treatment and future advances, Transl Lung Cancer Res. 2016 Jun; 5(3): 288–300. iv Polanco D et al. Prognostic value of symptoms at lung cancer diagnosis: a three-year observational study. J Thorac Dis 2021;13:1485–1494 v National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). (Accessed: August 2024). vi Arcila, M. E. et al. Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas. Clin. cancer Res. an Off. J. Am. Assoc. Cancer Res. 18, 4910–4918 (2012). MPR-US-103284 8/24 SOURCE Boehringer Ingelheim

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100 Deals associated with Brigimadlin

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Soft Tissue Sarcoma	Phase 3	-	Boehringer Ingelheim GmbH	27 Jun 2024
myxoid MFH	Phase 3	-	Boehringer Ingelheim GmbH	27 Jun 2024
Dedifferentiated Liposarcoma	Phase 3	China	Boehringer Ingelheim GmbH	31 Mar 2022
Dedifferentiated Liposarcoma	Phase 3	Belgium	Boehringer Ingelheim (China) Investment Co., Ltd.	31 Mar 2022
Dedifferentiated Liposarcoma	Phase 3	Czechia	Boehringer Ingelheim (China) Investment Co., Ltd.	31 Mar 2022
Dedifferentiated Liposarcoma	Phase 3	Denmark	Boehringer Ingelheim (China) Investment Co., Ltd.	31 Mar 2022
Dedifferentiated Liposarcoma	Phase 3	Denmark	Boehringer Ingelheim GmbH	31 Mar 2022
Dedifferentiated Liposarcoma	Phase 3	Finland	Boehringer Ingelheim (China) Investment Co., Ltd.	31 Mar 2022
Dedifferentiated Liposarcoma	Phase 3	France	Boehringer Ingelheim GmbH	31 Mar 2022
Dedifferentiated Liposarcoma	Phase 3	France	Boehringer Ingelheim (China) Investment Co., Ltd.	31 Mar 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05218499 (Brightline-1, CTgov)	Phase 2/3	Dedifferentiated Liposarcoma	400	Brigimadlin (Brigimadlin 30 mg q3w)	kdebdweabt(ajhkkxwsjm) = dvdjadgsmk kggeqpxecx (wmelergsrz, kpejkwwzii - mjyyxxtkqd) View more	-	04 Jul 2025
				Brigimadlin (Brigimadlin 45 mg q3w)	kdebdweabt(ajhkkxwsjm) = geoxlpzhds kggeqpxecx (wmelergsrz, oxurdrvrtb - hlhksamkyx) View more
NCT03449381 \| NCT05512377 \| NCT03964233 (WCLC2024) Manual	Phase 1/2	Advanced Lung Adenocarcinoma MDM2 Amplification	16	Brigimadlin 45 mg q3w	ghvaneocxz(mhxkqwjqgq) = In patients who received brigimadlin 45 mg q3w in the Phase Ia/Ib monotherapy (n=140)/combination trials (n=74), the most common any-grade treatment-related adverse events (TRAEs) were nausea (67.9%/70.3%) and fatigue (53.6%/39.2%), respectively. qoibnqnedf (tinihfjzrs ) View more	Positive	09 Sep 2024
				brigimadlin + ezabenlimab (Phase Ia/Ib)
NCT03449381 (ESMO_SRC2024) Manual	Phase 1	Liposarcoma MDM2 Amplification	190	Brigimadlin (BI 907828) 45 mg q3w	qeifbwmfrg(iktdsjiyvl) = pitrweaadx dfjnlvygnl (wgqivusicc ) View more	Positive	15 Mar 2024
NCT03449381 (ESMO_SRC2024) Manual	Phase 1	Dedifferentiated Liposarcoma	90	Brigimadlin	ukqbvquilo(pgdxlltjam) = rqnctmvgqj nbauhneggh (dokfkitivd ) View more	Positive	14 Mar 2024
NCT05512377 (ESMO2023)	Phase 1	Lung Cancer \| Solid tumor \| Pancreatic Ductal Adenocarcinoma ... View more	-	BI 907828	rttsosnojy(mridwglqyn) = dkqlhrnvlp thfmeegpta (pznlyenhvg ) View more	-	23 Oct 2023
NCT03449381 (ASCO2023) Manual	Phase 1	Dedifferentiated Liposarcoma	73	BI 907828 45 mg	xuqqszkmeq(benynmvjez) = pptwratvtf upjvvzdjeu (svncbfkrht ) View more	Positive	31 May 2023
NCT03449381 \| NCT03964233 (ASCO_GI2023) Manual	Phase 1	Advanced Bile Duct Carcinoma MDM2 Expression	8	BI 907828	ftiptlcnra(luqzbhueqf) = sarwolvwmy yzbcsfzniw (jjlfkzaxqr ) View more	Positive	24 Jan 2023
				BI 907828+Ezabenlimab 240 mg±BI 754111	cfqreqthxb(lhxfzwvwoe) = qxadglikhi eszqsuuuvy (ifxkkjzgrc ) View more
NCT03449381 (ESMO2022) Manual	Phase 1	Neoplasms MDM2 Amplification \| TP53 Wild-type	94	BI 907828 45 mg	ttrsyayuwp(slszesjipd) = jyptnhzrsz rcetgljakh (bshweoxvvl ) View more	Positive	10 Sep 2022
				BI 907828 45 mg (DDLPS)	wyoaaazywb(gvemeydhdw) = yusurfbswt ehxeidlcky (hiergxfmti ) View more
NCT03449381 (ASCO2022) Manual	Phase 1	Solid tumor \| Advanced Liposarcoma	90	BI 907828	rrfzploiyv(alhslarltx) = jjxdukfqmd pjzeeprbao (hghwnszztb ) View more	Positive	02 Jun 2022
				BI 907828 (DDLPS)	fnsvbqsnbw(lqwmiyyveq) = epfdjxkvqe asvzkxtuqg (nmhtewihck ) View more
NCT03964233 (ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	26	BI 907828+ezabenlimab+BI 754111	aqiujoempm(wgwolhiqeh) = iyzwgjvirc rjbivmvtrp (eauytayeob ) View more	Positive	02 Jun 2022
				BI 907828+ezabenlimab	aqiujoempm(wgwolhiqeh) = dvpvhvhmlb rjbivmvtrp (eauytayeob ) View more

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