Brightline-2: A Phase IIa/IIb, Open-label, Single-arm, Multi-centre Trial of BI 907828 (Brigimadlin) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT05512377

Title field or adapter rule

{'original_value': 'Brightline-2: A Phase IIa/IIb, Open-label, Single-arm, Multi-centre Trial of BI 907828 (Brigimadlin) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:23.469925+00:00

Published At

2026-10-14T00:00:00+00:00

Record Updated At

2026-10-14

Results Posted At

2026-10-14

Source Retrieved At

2026-10-31T22:17:52.415050+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Pancreatic Neoplasms", "Solid Tumors", "Biliary Tract Cancer", "Lung Neoplasms", "Bladder Cancer"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-14", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT05512377"

protocolSection.identificationModule.officialTitle

"Brightline-2: A Phase IIa/IIb, Open-label, Single-arm, Multi-centre Trial of BI 907828 (Brigimadlin) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

{"date": "2026-10-14", "type": "ACTUAL"}

Study condition terms

• Pancreatic Neoplasms (protocolSection.conditionsModule.conditions)
• Solid Tumors (protocolSection.conditionsModule.conditions)
• Biliary Tract Cancer (protocolSection.conditionsModule.conditions)
• Lung Neoplasms (protocolSection.conditionsModule.conditions)
• Bladder Cancer (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Brigimadlin 45 mg: Cohort 1 (biliary tract adenocarcinoma)', 'Brigimadlin 45 mg: Cohort 2 (pancreatic ductal adenocarcinoma)', 'Brigimadlin 45 mg: Cohort 3 (lung adenocarcinoma)', 'Brigimadlin 45 mg: Cohort 4 (urothelial bladder cancer)'], 'description': 'Patients received brigimadlin 45 mg orally on Day 1 of each 21-day cycle.', 'name': 'Brigimadlin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• Brigimadlin (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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