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Brief Title: Brightline-2: A Study to Test Whether BI 907828 Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

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

INTRODUCTION

  • Org Study ID: 1403-0011
  • Secondary ID: N/A
  • NCT ID: NCT05512377
  • Sponsor: Boehringer Ingelheim

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    November 25, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Pancreatic Neoplasms
  • Solid Tumors
  • Biliary Tract Cancer
  • Lung Neoplasms
  • Bladder Cancer

ELIGIBILITY

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.
Exclusion Criteria:
* 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Boehringer Ingelheim, Additional US locations available on demand. Please contact for options.

Phone: 1-800-243-0127, 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

LOCATION

Facility Status Contact
Facility: University of Arizona
Tucson, Arizona 85719
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Precision NextGen Oncology
Beverly Hills, California 90212
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: University of Southern California
Los Angeles, California 90033-9173
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Stanford Cancer Institute
Palo Alto, California 94305
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Providence Medical Foundation
Santa Rosa, California 95403
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Rocky Mountain Cancer Centers
Lone Tree, Colorado 80124
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital
Washington, District of Columbia 20016
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Norton Cancer Institute, Downtown
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: University of Michigan Health System
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Memorial Sloan-Kettering Cancer Center
New York, New York 10022
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: Oregon Health and Sciences University
Portland, Oregon 97239
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Facility: University of Wisconsin
Madison, Wisconsin 53792
United States
Status: Recruiting Contact: Contact
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com