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A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04958239
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:

This study is open to adults with advanced cancer (solid tumors). People for whom previous treatment was not successful can take part in this study.

The purpose of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab.

Each participant is put into one of two groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks.

BI 765179 and ezabenlimab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time.

Participants can stay in the study up to 3 years if they benefit from treatment and can tolerate it.

The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.


Condition or disease Intervention/treatment Phase
Neoplasms Drug: BI 765179 Drug: Ezabenlimab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase I Dose-finding Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers
Actual Study Start Date : September 24, 2021
Estimated Primary Completion Date : September 13, 2024
Estimated Study Completion Date : July 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: BI 765179 Drug: BI 765179
BI 765179
Experimental: Arm B: BI 765179 + ezabenlimab Drug: BI 765179
BI 765179

Drug: Ezabenlimab
Ezabenlimab


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Up to Day 21 (end of Cycle 1) ]
    MTD is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD will be assessed based on the number of patients experiencing DLTs, graded according to Common terminology criteria for adverse events (CTCAE) version 5.0, during the MTD evaluation period.

  2. Number of patients experiencing Dose Limiting Toxicities (DLTs) in the MTD evaluation period [ Time Frame: Up to Day 21 (end of Cycle 1) ]

Secondary Outcome Measures :
  1. Number of patients experiencing DLTs during the on-treatment period (per arm) [ Time Frame: up to 36 months ]
  2. Maximum measured concentration of BI 765179 in plasma (Cmax) [ Time Frame: Up to Day 21 (end of Cycle 1) ]
  3. Area under the concentration-time curve of BI 765179 in plasma over a uniform dosing interval from zero to 504h (AUC0-504) [ Time Frame: Up to Day 21 (end of Cycle 1) ]
  4. Maximum measured concentration of BI 765179 in plasma at steady state (Cmax,ss) [ Time Frame: up to Day 84 (end of Cycle 4) ]
  5. Area under the concentration-time curve of BI 765179 in plasma at steady state over a uniform dosing interval 504h (AUC0-504,ss) [ Time Frame: Up to Day 84 (end of Cycle 4) ]

Eligibility Criteria
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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:

  • All cohorts:
  • Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate

  • Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies:

    • Non-small cell lung carcinoma (NSCLC)
    • Gastric cancer
    • Esophageal adenocarcinoma or squamous cell carcinoma
    • Urothelial bladder carcinoma
    • Head and neck squamous cell carcinoma
    • Cutaneous malignant melanoma
    • Cutaneous squamous cell carcinoma
    • Hepatocellular carcinoma
    • Pancreatic adenocarcinoma
    • Colorectal cancer
    • Malignant pleural mesothelioma
    • Cervical squamous cell cancer
    • Ovarian carcinoma
    • Triple-negative breast cancer
  • At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
  • Signed and dated, written informed consent (IC) in accordance with ICH-GCP and local legislation prior to admission to the trial
  • At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response evaluation criteria in solid tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate liver, bone marrow and renal organ function
  • Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be ready and able to use highly effective 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. These methods must be used during the study and for at least 6 months after the last dose of the study medication. A list of contraception methods meeting these criteria is provided in the patient information.

  • Patients with brain metastases are eligible provided they meet all of the following criteria:

    • brain metastases have adequately been treated and are considered stable by the Investigator
    • radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 765179
    • patient is off steroids for at least 7 days (physiologic doses of steroids is permitted, if this was stable for the last 4 weeks)
    • the patient is off anti-epileptic drugs for at least 7 days

Back-fill cohorts only:

  • Patient has agreed to and signed an informed consent (IC) form to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
  • At least one lesion (separate from the evaluable target lesion outside of the CNS as defined per RECIST v1.1) that is accessible for mandatory paired pre and on-treatment biopsy

Exclusion Criteria:

  • Currently enrolled in another investigational device or drug trial

  • Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:

    • effectively treated non-melanoma skin cancers
    • effectively treated carcinoma in situ of the cervix
    • effectively treated ductal carcinoma in situ
    • other effectively treated malignancy that is considered cured by 'local treatment'
  • Previous treatment with agents targeting CD137
  • Known leptomeningeal disease or spinal cord compression due to disease
  • Anticoagulant treatment that cannot be safely interrupted if medically needed (e.g., biopsy) based on the opinion of the Investigator
  • Persistent toxicity from previous treatments that has not resolved to ≤ Common terminology criteria for adverse events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy)
  • Patient has a diagnosis of immunodeficiency

  • Patient with history of immunosuppressive medication within 14 days prior to the first dose of BI 765179. The following are exceptions to this criterion:

    • Use of intranasal, inhaled, or topical corticosteroids, local steroid injections (e.g., intra-articular injections)
    • Systemic corticosteroids at physiologic doses ≤10 mg/day (prednisone or equivalent)
    • Physiological replacement dose of corticosteroids
Contacts and Locations
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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): NCT04958239


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

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85719
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Belgium
Brussels - UNIV Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Boehringer Ingelheim    080049616    belgique@bitrialsupport.com   
Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale Recruiting
Napoli, Italy, 80131
Contact: Boehringer Ingelheim    800977373    italia@bitrialsupport.com   
Japan
National Cancer Center Hospital East Recruiting
Chiba, Kashiwa, Japan, 277-8577
Contact: Boehringer Ingelheim    0120201230    nippon@bitrialsupport.com   
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081HV
Contact: Boehringer Ingelheim    08000204613    nederland@bitrialsupport.com   
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Clínica Universidad de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04958239    
Other Study ID Numbers: 1463-0001
2021-000234-34 ( EudraCT Number )
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: 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