NCT05512377 is a Phase 2 clinical trial of brigimadlin in Pancreatic Neoplasms, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT05512377?

NCT05512377 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT05512377?

Interventions in NCT05512377: brigimadlin.

What condition does NCT05512377 study?

NCT05512377 studies Pancreatic Neoplasms, Solid Tumors, Biliary Tract Cancer, Lung Neoplasms, Bladder Cancer.

Is NCT05512377 still recruiting?

NCT05512377 is currently completed. Last updated 21 January 2026.

Last reviewed 2026-01-21 · How we verify

NCT05512377

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

Completed Phase 2 Last updated 21 January 2026

What this trial tests

Phase 2 trial testing brigimadlin in Pancreatic Neoplasms in 99 participants. Completed in 25 September 2025.

Timeline

13 December 2022

Primary endpoint
25 September 2025

25 September 2025

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	99
Start date	13 December 2022
Primary completion	25 September 2025
Estimated completion	25 September 2025
Sites	60 locations across France, South Africa, Japan, Belgium, Austria, Saudi Arabia, Taiwan, United Kingdom

Drugs / interventions tested

brigimadlin — full drug profile →

Conditions studied

Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →
Solid Tumors — all drugs for Solid Tumors →
Biliary Tract Cancer — all drugs for Biliary Tract Cancer →
Lung Neoplasms — all drugs for Lung Neoplasms →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Pancreatic Neoplasms or Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting p53 pathways: mechanisms, structures, and advances in therapy.
Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1
The roles of E3 ubiquitin ligases in cancer progression and targeted therapy.
Sampson C, Wang Q, Otkur W, Zhao H, et al · · 2023 · cited 105× · PMID 36881608 · DOI 10.1002/ctm2.1204
MDM2 Inhibitors for Cancer Therapy: The Past, Present, and Future.
Wang W, Albadari N, Du Y, Fowler JF, et al · · 2024 · cited 85× · PMID 38697854 · DOI 10.1124/pharmrev.123.001026
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.
LoRusso P, Yamamoto N, Patel MR, Laurie SA, et al · · 2023 · cited 67× · PMID 37269344 · DOI 10.1158/2159-8290.cd-23-0153
Brightline-2: a phase IIa/IIb trial of brigimadlin (BI 907828) in advanced biliary tract cancer, pancreatic ductal adenocarcinoma or other solid tumors.
Yoo C, Lamarca A, Choi HJ, Vogel A, et al · · 2024 · cited 18× · PMID 38214149 · DOI 10.2217/fon-2023-0963
Ubiquitin modification in the regulation of tumor immunotherapy resistance mechanisms and potential therapeutic targets.
Hong Z, Liu F, Zhang Z. · · 2024 · cited 16× · PMID 39223632 · DOI 10.1186/s40164-024-00552-0
New systemic treatment options for advanced cholangiocarcinoma.
Zanuso V, Tesini G, Valenzi E, Rimassa L. · · 2024 · cited 13× · PMID 39113642 · DOI 10.17998/jlc.2024.08.07
Discovery and Characterization of Brigimadlin, a Novel and Highly Potent MDM2-p53 Antagonist Suitable for Intermittent Dose Schedules.
Gollner A, Rudolph D, Weyer-Czernilofsky U, Baumgartinger R, et al · · 2024 · cited 11× · PMID 39259562 · DOI 10.1158/1535-7163.mct-23-0783

Verify or expand the search:

Other recruiting trials for Pancreatic Neoplasms

Currently open trials in the same condition.

NCT07504471 — Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhib · Phase 2 · recruiting
NCT07139236 — Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD · recruiting
NCT06885697 — Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Includi · Phase 1 · recruiting
NCT06939023 — Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3) · NA · recruiting
NCT06953193 — Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia · NA · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05512377 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 21 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05512377.

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