Last reviewed · How we verify
NCT06619509
A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Phase 2 trial testing Brigimadlin in Solid Tumours in 90 participants. Participants enrolled and being followed up; not accepting new ones.
30 December 2030
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 30 December 2024 |
| Primary completion | 30 December 2030 |
| Estimated completion | 30 December 2030 |
| Sites | 50 locations across Italy, Japan, Taiwan, Poland, Denmark, Belgium, Sweden, United States |
Drugs / interventions tested
- Brigimadlin — full drug profile →
Conditions studied
- Solid Tumours — all drugs for Solid Tumours →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
18 and older, any sex, with Solid Tumours. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Ubiquitination mediated by RING-type E3 ligases in the progression of digestive system tumors: mechanistic insights and potential therapeutic strategies.
Wu Y, Yu X, Guan C, Zhao M. · · 2026 · PMID 42245480 · DOI 10.3389/fcell.2026.1809222 -
Targeting MDM2, RAS, and PCNA for cancer targeted therapy: pan-cancer approaches vs. cancer-specific strategies.
Wang W, Alley A, Sun N, Tadesse M, et al · · 2025 · PMID 41170373 · DOI 10.3389/fphar.2025.1663766
Verify or expand the search:
- PubMed search for NCT06619509
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Brigimadlin
Trials testing the same drug.
- NCT06370871 — Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Ti · Phase 3 · withdrawn
- NCT06058793 — Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated · Phase 3 · completed
- NCT05218499 — Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dediffe · Phase 2, PHASE3 · completed
Other recruiting trials for Solid Tumours
Currently open trials in the same condition.
- NCT07391670 — A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durval · Phase 1 · recruiting
- NCT07446855 — Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homo · Phase 1, PHASE2 · recruiting
- NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
- NCT07165067 — A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
- NCT07403370 — Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis · 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)
- Trial protocol + status: ClinicalTrials.gov NCT06619509 (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: 14 April 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/NCT06619509.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing