RECRUITING

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

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Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 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. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer. In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein. BI 765179, ezabenlimab, and pembrolizumab 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 2 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.

Official Title

An Open Label, Phase I Dose-finding and Expansion Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers, and BI 765179 in Combination With Pembrolizumab in First-line PD-L1-positive Metastatic or Incurable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Quick Facts

Study Start:2021-10-18
Study Completion:2028-11-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04958239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies:
  3. * Non-small cell lung carcinoma (NSCLC)
  4. * Gastric cancer
  5. * Esophageal adenocarcinoma or squamous cell carcinoma
  6. * Urothelial bladder carcinoma
  7. * Head and neck squamous cell carcinoma
  8. * Cutaneous malignant melanoma
  9. * Cutaneous squamous cell carcinoma
  10. * Hepatocellular carcinoma
  11. * Pancreatic adenocarcinoma
  12. * Colorectal cancer
  13. * Malignant pleural mesothelioma
  14. * Cervical squamous cell cancer
  15. * Ovarian carcinoma
  16. * Triple-negative breast cancer
  17. * 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
  18. * Signed and dated, written informed consent (IC) in accordance with ICH-GCP and local legislation prior to admission to the trial
  19. * At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response evaluation criteria in solid tumors (RECIST) v1.1
  20. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  21. * Adequate liver, bone marrow and renal organ function
  22. * Male or female patients. Women of childbearing potential (WOCBP) 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.
  23. * Patients with brain metastases are eligible provided they meet all of the following criteria:
  24. * Brain metastases have adequately been treated and are considered stable by the Investigator
  25. * Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 765179
  26. * Patient is off steroids for at least 7 days (physiologic doses of steroids is permitted, if this was stable for the last 4 weeks)
  27. * The patient is off anti-epileptic drugs for at least 7 days
  28. * Patient has agreed to and signed an IC form to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
  29. * 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
  30. * Histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent head and neck squamous cell carcinoma (HNSCC)
  31. * No prior systemic therapy administered in the metastatic or incurable, recurrent setting
  32. * Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
  33. * 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
  34. * Signed and dated written IC in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply
  1. * Currently enrolled in another investigational device or drug trial
  2. * Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:
  3. * Effectively treated non-melanoma skin cancers
  4. * Effectively treated carcinoma in situ of the cervix
  5. * Effectively treated ductal carcinoma in situ
  6. * Other effectively treated malignancy that is considered cured by 'local treatment'
  7. * Previous treatment with agents targeting CD137
  8. * Known leptomeningeal disease or spinal cord compression due to disease
  9. * Anticoagulant treatment that cannot be safely interrupted if medically needed (e.g., biopsy) based on the opinion of the Investigator
  10. * 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)
  11. * Patient has a diagnosis of immunodeficiency
  12. * Patient with history of immunosuppressive medication within 14 days prior to the first dose of BI 765179. The following are exceptions to this criterion:
  13. * Use of intranasal, inhaled, or topical corticosteroids, local steroid injections (e.g., intra-articular injections)
  14. * Systemic corticosteroids at physiologic doses ≤10 mg/day (prednisone or equivalent)
  15. * Physiological replacement dose of corticosteroids Further exclusion criteria apply.
  16. * Disease suitable for local therapy administered with curative intent
  17. * Participants must not have a primary tumor site of nasopharynx or sino-nasal cancer or salivary gland cancers (any histology)
  18. * Currently enrolled in another investigational device or drug trial
  19. * Life expectancy of \<3 months and/or has rapidly progressing disease
  20. * Diagnosed and/or treated additional malignancy within 2 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or in situ breast cancers Further exclusion criteria apply

Contacts and Locations

Study Contact

Boehringer Ingelheim
CONTACT
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85719
United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
NEXT Oncology-San Antonio-65273
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-18
Study Completion Date2028-11-19

Study Record Updates

Study Start Date2021-10-18
Study Completion Date2028-11-19

Terms related to this study

Additional Relevant MeSH Terms

  • Neoplasms