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A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)

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ClinicalTrials.gov Identifier: NCT04147234
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This is a study in adults with advanced cancer (solid tumours) in whom previous treatment was not successful. The study tests 2 medicines called BI 1387446 and BI 754091. Both medicines may help the immune system fight cancer. In this study, BI 1387446 is given to humans for the first time.

The purpose of this study is to find out the highest dose of BI 1387446 alone and in combination with BI 754091 the participants can tolerate. BI 1387446 is injected directly into the tumour.

Participants get BI 1387446 injections every week at the beginning and then every 3 weeks.

Some participants get BI 754091 in addition to BI 1387446. BI 754091 is given as an infusion into a vein every 3 weeks.

As long as they benefit from treatment and can tolerate it, participants can stay in the study for up to 2 years and 8 months. During this time, they visit the study site regularly. At these visit, doctors record any unwanted effects. The doctors also regularly check participants' health.


Condition or disease Intervention/treatment Phase
Neoplasms Drug: BI 1387446 Drug: BI 754091 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, First in Human Trial Evaluating BI 1387446 Alone and in Combination With Ezabenlimab (BI 754091) in Solid Tumors
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : June 6, 2024
Estimated Study Completion Date : January 2, 2025

Arm Intervention/treatment
Experimental: Arm A: BI 1387446
superficial lesions
Drug: BI 1387446
intratumoral injection

Experimental: Arm B: BI 1387446 in combination with ezabenlimab (BI 754091)
superficial lesions
Drug: BI 1387446
intratumoral injection

Drug: BI 754091
intravenous infusion
Other Name: ezabenlimab

Experimental: Arm C: BI 1387446 in combination with ezabenlimab (BI 754091)
deep lesions
Drug: BI 1387446
intratumoral injection

Drug: BI 754091
intravenous infusion
Other Name: ezabenlimab




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) based on number of Dose-limiting toxicities (DLTs) [ Time Frame: 3 weeks ]
  2. Number of patients with Dose limiting Toxicity (DLT) in the Maximum tolerated dose (MTD) evaluation period [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Objective response [ Time Frame: An average of 1 year ]
  2. Best percentage change from baseline in size of injected target lesions [ Time Frame: An average of 1 year ]
  3. Best percentage change from baseline in size of non-injected target lesions [ Time Frame: An average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic malignant solid tumor and indication for treatment
  • Patient must have exhausted established treatment options known to prolong survival for the malignant disease, or is not eligible for established treatment options.
  • Medically fit and willing to undergo all mandatory trial procedures.
  • At least one tumor lesion which is suitable for injection (Screening/initial administration), appropriate for the allocated treatment arm, and measurable.
  • At least 1 discrete lesion, in addition to the lesion proposed for injection, which is amenable to biopsy and is not located in the brain, mediastinum or pancreas.
  • Adequate organ function or bone marrow reserve
  • Further inclusion criteria apply

Exclusion criteria:

  • Any investigational or antitumour treatment (including antibodies targeting Programmed Cell Death-1 (PD1) - or programmed Death-Ligand 1 (PDL1)) within 4 weeks or 5 half-life periods (whichever is shorter) prior to the initial administration of BI 1387446 or BI 754091.
  • Persistent toxicity from previous treatments (including Immune-related Adverse Events (irAEs)) that has not resolved to ≤ Grade 1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies which may be included if clinically stable on hormone supplements or antidiabetic drugs as per Investigator judgement
  • History or evidence of active, non-treatment related autoimmune disease, except for endocrinopathies which may be included if clinically stable on hormone supplements or antidiabetic drugs.
  • History or evidence of pneumonitis related to prior immunotherapy
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of BI 1387446 or BI 754091.
  • The tumor at the projected injection site has a high risk for local complications, e.g. bleeding related to encasement/infiltration of major blood vessels or contact with liver capsule, compression of vital structures in case of swelling of injected lesion, in the opinion of the Investigator.
  • Active infection requiring systemic therapy at the start of treatment in the trial, including active viral hepatitis infection or active tuberculosis infection.
  • Cardiac insufficiency New York Heart Association (NYHA) III or IV
  • Left ventricular ejection fraction < 50% measured by echocardiography or Multigated Acquisition (MUGA) scan
  • Mean resting corrected QT interval (QTc) >470 msec
  • Arm C: Patients on therapeutic doses of anticoagulants.
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147234


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, New York
Columbia University Medical Center-New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Matthew Ingham    +001 (646) 317-7141    mi2337@cumc.columbia.edu   
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Jared Weiss    +001 (919) 843-7718    jared_weiss@med.unc.edu   
United States, Wisconsin
Froedtert and The Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jonathan Thompson    +001 (414) 805-4600    jrthomps@mcw.edu   
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Elena Garralda    +34932746085    egarralda@vhio.net   
CIO Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Emiliano Calvo    +34902107469    emiliano.calvo@startmadrid.com   
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Andres Manuel Cervantes Ruiperez    +34961973527    andres.cervantes@uv.es   
United Kingdom
The Royal Marsden Hospital Recruiting
London, United Kingdom, SW3 6JJ
Contact: Kevin Harrington    0207 153 5157    kevin.harrington@icr.ac.uk   
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Eileen Parkes    01865 741841    eileen.parkes@oncology.ox.ac.uk   
The Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Kevin Harrington    0207 153 5157    kevin.harrington@icr.ac.uk   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04147234    
Other Study ID Numbers: 1426-0001
2019-001082-32 ( EudraCT Number )
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No