Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Boehringer Ingelheim (Voir sur ClinicalTrials)
décembre 2022
octobre 2025
07 août 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 20/02/2024 08:26:46 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CTR Georges-François Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Diagnosis of a solid tumour which meets the criteria for an open trial cohort:
- Cohorts 1 and 1-CN (biliary tract adenocarcinoma): Locally advanced or
metastatic biliary tract adenocarcinoma (intra- and extrahepatic
cholangiocarcinoma, gallbladder cancer, and ampullary cancer).Patients must
have unresectable disease and have received all available conventional
therapies known to confer clinical benefit for their disease based on local
approved standards; or (in the opinion of the investigator) patients are
unlikely to tolerate or derive clinically meaningful benefit from appropriate
standard of care therapy.
- Cohort 2 (pancreatic ductal adenocarcinoma): Locally advanced or metastatic
pancreatic ductal adenocarcinoma. Patients must have unresectable disease and
have received all available conventional therapies known to confer clinical
benefit for their disease based on local approved standards.
- Cohort 3 (lung adenocarcinoma): Locally advanced or metastatic lung
adenocarcinoma. Patients must have unresectable disease and have received all
available conventional therapies known to confer clinical benefit for their
disease based on local approved standards.
- Cohort 4 (urothelial bladder cancer): Locally advanced or metastatic urothelial
bladder cancer. Patients must have unresectable disease and have received all
available conventional therapies known to confer clinical benefit for their
disease based on local approved standards.
- 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. This must have been confirmed with a tissue-based test. A test
with liquid biopsy is not accepted.
- Archival tissue (formalin fixed paraffin embedded [FFPE] tumour blocks or slides)
must be provided for retrospective confirmation of MDM2 amplification and TP53
status.
- Presence of at least 1 measurable target lesion according to Response Evaluation
Criteria in Solid Tumours (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Patient must be willing to donate mandatory blood samples for the pharmacokinetics,
pharmacodynamics, and biomarker analyses
- Adequate organ function
- All toxicities related to previous anti-cancer therapies have resolved to ≤Common
Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment
administration (except for alopecia and amenorrhea / menstrual disorders which can
be of any grade and peripheral neuropathy which must be ≤CTCAE Grade 2).
- Life expectancy ≥3 months at the start of treatment in the opinion of the
investigator.
- Provision of signed and dated, written informed consent form (ICF) in accordance
with ICH-GCP and local legislation prior to any trial-specific procedures, sampling,
or analyses.
- Male or female patients ≥18 years old at the time of signature of the ICF. Women of
childbearing potential (WOCBP) and men able to father a child must be ready and able
to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result
in a low failure rate of less than 1% per year when used consistently and correctly
beginning at screening, during trial participation, and until 6 months and 12 days
after last dose for women and 102 days after last dose for men. A list of
contraception methods meeting these criteria is provided in the patient information.
- Diagnosis of a solid tumour which meets the criteria for an open trial cohort:
- Cohorts 1 and 1-CN (biliary tract adenocarcinoma): Locally advanced or
metastatic biliary tract adenocarcinoma (intra- and extrahepatic
cholangiocarcinoma, gallbladder cancer, and ampullary cancer).Patients must
have unresectable disease and have received all available conventional
therapies known to confer clinical benefit for their disease based on local
approved standards; or (in the opinion of the investigator) patients are
unlikely to tolerate or derive clinically meaningful benefit from appropriate
standard of care therapy.
- Cohort 2 (pancreatic ductal adenocarcinoma): Locally advanced or metastatic
pancreatic ductal adenocarcinoma. Patients must have unresectable disease and
have received all available conventional therapies known to confer clinical
benefit for their disease based on local approved standards.
- Cohort 3 (lung adenocarcinoma): Locally advanced or metastatic lung
adenocarcinoma. Patients must have unresectable disease and have received all
available conventional therapies known to confer clinical benefit for their
disease based on local approved standards.
- Cohort 4 (urothelial bladder cancer): Locally advanced or metastatic urothelial
bladder cancer. Patients must have unresectable disease and have received all
available conventional therapies known to confer clinical benefit for their
disease based on local approved standards.
- 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. This must have been confirmed with a tissue-based test. A test
with liquid biopsy is not accepted.
- Archival tissue (formalin fixed paraffin embedded [FFPE] tumour blocks or slides)
must be provided for retrospective confirmation of MDM2 amplification and TP53
status.
- Presence of at least 1 measurable target lesion according to Response Evaluation
Criteria in Solid Tumours (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Patient must be willing to donate mandatory blood samples for the pharmacokinetics,
pharmacodynamics, and biomarker analyses
- Adequate organ function
- All toxicities related to previous anti-cancer therapies have resolved to ≤Common
Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment
administration (except for alopecia and amenorrhea / menstrual disorders which can
be of any grade and peripheral neuropathy which must be ≤CTCAE Grade 2).
- Life expectancy ≥3 months at the start of treatment in the opinion of the
investigator.
- Provision of signed and dated, written informed consent form (ICF) in accordance
with ICH-GCP and local legislation prior to any trial-specific procedures, sampling,
or analyses.
- Male or female patients ≥18 years old at the time of signature of the ICF. Women of
childbearing potential (WOCBP) and men able to father a child must be ready and able
to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result
in a low failure rate of less than 1% per year when used consistently and correctly
beginning at screening, during trial participation, and until 6 months and 12 days
after last dose for women and 102 days after last dose for men. A list of
contraception methods meeting these criteria is provided in the patient information.
- Previous administration of brigimadlin (BI 907828) or any other MDM2-p53 or mouse
double minute 4 (MDMX, MDM4)-p53 antagonist.
- Active bleeding, significant risk of haemorrhage (e.g. previous severe
gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current
bleeding disorder (e.g. haemophilia, von Willebrand disease).
- Major surgery (major according to the investigator's assessment) performed within 4
weeks prior to start of trial treatment or planned within 6 months after screening
(e.g. hip replacement).
- Clinically significant previous or concomitant malignancies in the opinion of the
investigator affecting the efficacy and/or outcome of the trial.
- Patients who must or intend to continue the intake of restricted medications or any
drug considered likely to interfere with the safe conduct of the trial.
- Currently enrolled in another investigational device or drug trial.
- Any history of, or concomitant condition that, in the opinion of the investigator,
would compromise the patient's ability to comply with the trial or interfere with
the evaluation of the safety and efficacy of the trial drug.
- Patients not expected to comply with the protocol requirements or not expected to
complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other
condition that, in the investigator's opinion, makes the patient an unreliable trial
participant).
Further exclusion criteria apply.