BridgeMD
A study to test whether BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder
EU CTIS ID: 2023-506369-79-00
What this study is testing
To assess the efficacy, safety, and tolerability of BI 907828 monotherapy in the following cohorts of patients: Cohort 1: Biliary tract adenocarcinoma (cholangiocarcinoma, gallbladder cancer, and ampullary cancer) Cohort 2: Pancreatic ductal adenocarcinoma Cohort 3: Lung adenocarcinoma Cohort 4: Urothelial bladder cancer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of a solid tumour which meets the criteria for an open trial cohort: o Cohort 1 (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. o 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. o 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. o 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.
- 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 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.
- Written pathology report / molecular profiling report indicating MDM2 amplification or a copy number ≥8, and 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 RECIST version 1.1.
You likely can't join if
- Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
- Patients with known history of human immunodeficiency virus (HIV) infection who meet 1 or more of the following criteria: o CD4+ count <350 cells/μL o Viral load >400 copies/mL (local laboratory assessment) o Not receiving antiretroviral therapy o Receiving established antiretroviral therapy for <4 weeks prior to the start of trial treatment o History of AIDS-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the criteria above are eligible to participate but the patient must be under the care of a HIV/Infectious Diseases specialist or a HIV/Infectious Diseases specialist must be consulted prior to inclusion.
- Patients with a history of HCV infection who meet 1 or more of the following criteria: o Currently receiving curative antiviral treatment o Not yet achieved sustained viral response (SVR) o HCV viral load is above the limit of quantification (HCV RNA positive)
- Patients with chronic HBV infection with active disease who meet the criteria for anti- HBV therapy (according to local / institutional standard) and who have not been treated with suppressive antiviral therapy prior to initiation of trial treatment.
- Further exclusion criteria apply.
- 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).
See the full eligibility criteria
Who can join
- Diagnosis of a solid tumour which meets the criteria for an open trial cohort: o Cohort 1 (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. o 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. o 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. o 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.
- 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 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.
- Written pathology report / molecular profiling report indicating MDM2 amplification or a copy number ≥8, and 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 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, as specified in the protocol.
- All toxicities related to previous anti-cancer therapies have resolved to ≤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.
What rules you out
- Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
- Patients with known history of human immunodeficiency virus (HIV) infection who meet 1 or more of the following criteria: o CD4+ count <350 cells/μL o Viral load >400 copies/mL (local laboratory assessment) o Not receiving antiretroviral therapy o Receiving established antiretroviral therapy for <4 weeks prior to the start of trial treatment o History of AIDS-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the criteria above are eligible to participate but the patient must be under the care of a HIV/Infectious Diseases specialist or a HIV/Infectious Diseases specialist must be consulted prior to inclusion.
- Patients with a history of HCV infection who meet 1 or more of the following criteria: o Currently receiving curative antiviral treatment o Not yet achieved sustained viral response (SVR) o HCV viral load is above the limit of quantification (HCV RNA positive)
- Patients with chronic HBV infection with active disease who meet the criteria for anti- HBV therapy (according to local / institutional standard) and who have not been treated with suppressive antiviral therapy prior to initiation of trial treatment.
- Further exclusion criteria apply.
- 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).
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of trial treatment until 6 months and 12 days after last dose of trial treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- South Africa
- Australia
- Singapore
- Korea, Republic of
- Japan
- Taiwan
- Saudi Arabia
- United States
- United Kingdom
- Thailand
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; South Africa; Australia; Singapore; Korea, Republic of; Japan and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.