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Association details:
| Biomarker: | TP53 wild-type |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | brigimadlin (BI 907828) (MDM2-p53 antagonist) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
Excerpt:
...- Written pathology report / molecular profiling report indicating Mouse double minute 2 homolog (MDM2) amplification or a copy number ≥8 and tumor protein 53 (TP53) wild-type status....
Trial ID:
Source:
Title:
A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor
Excerpt:
...Patient has a tumour with either a known Tumor Protein p53 (TP53) wild type status, or unknown TP53 status, at the time of study entry....
Trial ID:
More C2 evidence
Source:
Title:
This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)
Excerpt:
...- 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....
Trial ID:
Source:
Title:
A Study to Determine How BI 907828 (Brigimadlin) is Taken up in the Tumor (Phase 0) and to Determine the Highest Dose of BI 907828 (Brigimadlin) That Could be Tolerated (Phase 1a) in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma
Excerpt:
...- Histologically demonstrated diagnosis of TP53 wild type glioblastoma harboring unmethylated O6-methylguanine-DNA-methyltransferase (MGMT) promoters....
Trial ID:
Source:
Title:
A study to test whether BI 907828 helps people with cancer in the biliary tract or pancreas Un estudio para evaluar si BI 907828 ayuda a las personas con cáncer en las vías biliares o el páncreas
Excerpt:
...Written pathology report / molecular profiling report indicating MDM2 amplification (copy number ≥8) and TP53 wild-type status.3. ...
Trial ID:
Less C2 evidence
Source:
Title:
452O - A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumours
Published date:
09/05/2022
Excerpt:
Disease control rate (complete + partial response (PR) + stable disease) was 93%/88% in pts with DDLPS/well-differentiated LPS (WDLPS), respectively. A confirmed PR was achieved in 5 pts (2 DDLPS, 3 WDLPS); 3 pts (2 DDLPS, 1 WDLPS) had an unconfirmed PR. Of the pts enrolled into phase Ia, 5/11 with DDLPS and 4/8 with WDLPS achieved a PFS >10.5 months. For pts with other solid tumours, 2/4 with MDM2-amplified biliary tract cancer and 1 with MDM2-amplified pancreatic adenocarcinoma had a confirmed PR.
Trial ID:
