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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 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: 2022-001500-18
  • NTC ID: NCT05512377
  • Sponsor: Boehringer Ingelheim
Related Info

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: Objective response (OR)

Primary Outcome 1 - Timeframe: Up to 30 months

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:
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.

- 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 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: N/A

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

Email: clintriage.rdg@boehringer-ingelheim.com

LOCATION

Facility Status Contact
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: Nebraska Cancer Specialists
Omaha, Nebraska 68130
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
Facility: ICON
South Brisbane, Queensland 4101
Australia
Status: Recruiting Contact: Contact
Boehringer Ingelheim
1800271035
australia@bitrialsupport.com
Facility: Edegem - UNIV UZ Antwerpen
Edegem, 2650
Belgium
Status: Recruiting Contact: Contact
Boehringer Ingelheim
080049616
belgique@bitrialsupport.com
Facility: UNIV UZ Gent
Gent, 9000
Belgium
Status: Recruiting Contact: Contact
Boehringer Ingelheim
080049616
belgique@bitrialsupport.com
Facility: HOP Edouard Herriot
Lyon, 69437
France
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0805102354
france@bitrialsupport.com
Facility: INS Gustave Roussy
Villejuif, 94805
France
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0805102354
france@bitrialsupport.com
Facility: Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Germany
Status: Recruiting Contact: Contact
Boehringer Ingelheim
08007234742
deutschland@bitrialsupport.com
Facility: Medizinische Hochschule Hannover
Hannover, 30625
Germany
Status: Recruiting Contact: Contact
Boehringer Ingelheim
08007234742
deutschland@bitrialsupport.com
Facility: Universitätsklinikum Ulm
Ulm, 89081
Germany
Status: Recruiting Contact: Contact
Boehringer Ingelheim
08007234742
deutschland@bitrialsupport.com
Facility: National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Japan
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0120201230
nippon@bitrialsupport.com
Facility: Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Japan
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0120201230
nippon@bitrialsupport.com
Facility: Tohoku University Hospital
Miyagi, Sendai, 980-8574
Japan
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0120201230
nippon@bitrialsupport.com
Facility: Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Japan
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0120201230
nippon@bitrialsupport.com
Facility: National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Japan
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0120201230
nippon@bitrialsupport.com
Facility: Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0808802084
namhan@bitrialsupport.com
Facility: Severance Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0808802084
namhan@bitrialsupport.com
Facility: Asan Medical Center
Seoul, 05505
Korea, Republic of
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0808802084
namhan@bitrialsupport.com
Facility: Samsung Medical Center
Seoul, 135-710
Korea, Republic of
Status: Recruiting Contact: Contact
Boehringer Ingelheim
0808802084
namhan@bitrialsupport.com
Facility: National University Hospital
Singapore, 119074
Singapore
Status: Recruiting Contact: Contact
Boehringer Ingelheim
8001207344
singapore@bitrialsupport.com
Facility: Hospital Vall d'Hebron
Barcelona, 08035
Spain
Status: Recruiting Contact: Contact
Boehringer Ingelheim
900876092
espana@bitrialsupport.com
Facility: Fundación Jiménez Díaz
Madrid, 28040
Spain
Status: Recruiting Contact: Contact
Boehringer Ingelheim
900876092
espana@bitrialsupport.com
Facility: Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Status: Recruiting Contact: Contact
Boehringer Ingelheim
900876092
espana@bitrialsupport.com
Facility: Hospital Clínico de Valencia
Valencia, 46010
Spain
Status: Recruiting Contact: Contact
Boehringer Ingelheim
900876092
espana@bitrialsupport.com
Facility: Chulabhorn Hospital
Bangkok, 10210
Thailand
Status: Recruiting Contact: Contact
Boehringer Ingelheim
1800019059
thai@bitrialsupport.com
Facility: Maharaj Nakom Chiangmai Hospital
Chiang Mai, 50200
Thailand
Status: Recruiting Contact: Contact
Boehringer Ingelheim
1800019059
thai@bitrialsupport.com
Facility: Songklanagarind Hospital
Hat Yai, 90110
Thailand
Status: Recruiting Contact: Contact
Boehringer Ingelheim
1800019059
thai@bitrialsupport.com
Facility: Srinagarind Hospital
Muang, 40002
Thailand
Status: Recruiting Contact: Contact
Boehringer Ingelheim
1800019059
thai@bitrialsupport.com