brigimadlin (BI 907828) / Boehringer Ingelheim - LARVOL DELTA

A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | N=31 ➔ 90

Enrollment change • Enrollment closed • Oncology • Solid Tumor

A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine (clinicaltrials.gov) - P2 | N=31 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Boehringer Ingelheim | N=31 ➔ 90

Enrollment change • Oncology • Solid Tumor

A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine (clinicaltrials.gov) - P2 | N=31 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma (clinicaltrials.gov) - P2/3 | N=400 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Liposarcoma • Oncology • Sarcoma • Solid Tumor • MDM2

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=267 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Apr 2026 ➔ Jun 2025 | Trial primary completion date: Mar 2026 ➔ Jun 2025

Trial completion date • Trial primary completion date • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=267 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=269 | Recruiting | Sponsor: Boehringer Ingelheim | Phase classification: P1a/1b ➔ P1 | N=204 ➔ 269

Enrollment change • Phase classification • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Mar 2023 ➔ Aug 2023

Trial completion date • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=102 | Recruiting | Sponsor: Boehringer Ingelheim | Phase classification: P1 ➔ P1a/1b | N=200 ➔ 102

Enrollment change • Phase classification • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=204 | Recruiting | Sponsor: Boehringer Ingelheim | N=114 ➔ 204

Enrollment change • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=114 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jun 2024 ➔ Jun 2026 | Trial primary completion date: Mar 2023 ➔ Mar 2026

Trial completion date • Trial primary completion date • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=114 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Feb 2024 ➔ Jun 2024 | Trial primary completion date: Nov 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=102 | Recruiting | Sponsor: Boehringer Ingelheim | Suspended ➔ Recruiting | Trial completion date: Aug 2023 ➔ Nov 2023 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Enrollment open • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=102 | Suspended | Sponsor: Boehringer Ingelheim | Recruiting ➔ Suspended

Trial suspension • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=102 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jan 2023 ➔ Aug 2023 | Trial primary completion date: Oct 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1a/1b | N=102 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jun 2023 ➔ Jan 2023 | Trial primary completion date: Feb 2022 ➔ Oct 2021

Trial completion date • Trial primary completion date • Cholangiocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov) - P1 | N=119 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Biliary Tract Cancer • Cholangiocarcinoma • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

Pharmacokinetic-pharmacodynamic-efficacy modeling of the MDM2 inhibitor brigimadlin in glioblastoma patient-derived xenografts. (PubMed, Neurooncol Adv) - "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."

Journal • PK/PD data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • ABCG2 • MDM2 • RAG1

A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov) - P1 | N=119 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: May 2026 ➔ Feb 2026

Trial completion date • Biliary Tract Cancer • Cholangiocarcinoma • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. (ASCO-GI 2023) - P1a/1b, P2a/2b | "Patients in the combination trial received escalating doses of BI 907828 and 240 mg ezabenlimab q3w (doublet); one patient also received the anti-LAG-3 antibody BI 754111 (a drug that has since been discontinued; triplet). The MDM2–p53 antagonist BI 907828 has shown a manageable safety profile and encouraging preliminary efficacy in patients with BTC, with 5 PRs and 2 SD in 8 patients. A phase IIa/IIb trial of BI 907828 (45 mg q3w) in patients with BTC is planned to start recruitment at the end of 2022 (NCT05512377). Clinical trial information: NCT03449381 and NCT03964233."

Clinical • IO biomarker • Metastases • P1 data • Ampulla of Vater Carcinoma • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MDM2 • TP53

A PHASE IA/IB, DOSE-ESCALATION/EXPANSION STUDY OF THE MDM2–P53 ANTAGONIST BI 907828 IN PATIENTS WITH SOLID TUMORS, INCLUDING ADVANCED/METASTATIC LIPOSARCOMA (CTOS 2022) - No abstract available

Clinical • P1 data • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Brightline-1: phase II/III trial of the MDM2-p53 antagonist BI 907828 versus doxorubicin in patients with advanced DDLPS. (PubMed, Future Oncol) - P2/3 | "BI 907828 has shown promising activity in preclinical studies and in a phase Ia/Ib study in patients with solid tumors, particularly those with DDLPS. This manuscript describes the rationale and design of an ongoing multicenter, randomized, phase II/III trial (Brightline-1; NCT05218499) evaluating BI 907828 versus doxorubicin as first-line treatment for advanced DDLPS."

Journal • Metastases • P2/3 data • Review • Liposarcoma • Oncology • Sarcoma • Solid Tumor • MDM2