A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

December 11, 2023 updated by: Boehringer Ingelheim

Phase Ia, First in Human Open Label Dose Escalation Trial Evaluating Intravenous BI 1703880 in Combination With Intravenous Ezabenlimab for Treatment of Advanced Solid Tumours

This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists.

The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time.

Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks.

Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Chiba, Kashiwa, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28050
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
        • Contact:
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
      • Oxford, United Kingdom, OX3 7LE
      • Sutton, United Kingdom, SM2 5PT
  • United States
    • California
      • Los Angeles, California, United States, 90067
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • New Jersey
      • Hackensack, New Jersey, United States, 07601

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).
  • Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.
  • Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies.
  • Medically fit and willing to undergo all mandatory trial procedures.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

  • Adequate organ function or bone marrow reserve as demonstrated at screening by the following laboratory values:

    • Absolute neutrophil count ≥ 1.5x10^9/L (≥ 1.5x10^3/μL, ≥ 1500/mm3); platelet count ≥ 100x10^9/L (≥ 100x10^3/μL, ≥ 100x10^3/mm3), without the use of hematopoietic growth factors within 4 weeks of start of trial medication
    • Haemoglobin ≥ 90 g/L (≥ 9.0 g/dL, ≥ 5.6 mmol/L)
    • Estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73m^2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
    • Total bilirubin ≤ 1.5 x ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
    • partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT) <1.5 x ULN
  • Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).
  • Signed and dated written ICF in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation, obtained before performing any protocol related procedures that are not part of normal standard of practice care. Note: If a patient declines to participate in the voluntary biobanking component of the trial, he/she will not be excluded from other aspects of the trial.

Further inclusion criteria apply

Exclusion Criteria:

  • Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
  • Prior STING agonist therapy.
  • Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
  • History of allergy or hypersensitivity to study agent components.
  • Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding >10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers.
  • 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.
  • Evidence of active, non-treatment related autoimmune disease, except for endocrinopathies.
  • History or complication of pneumonitis or interstitial lung disease within the last 12 months, or any prior pneumonitis related to immunotherapy.

Further exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)
Drug: Ezabenlimab
Ezabenlimab
Other Names:
  • BI 754091
Drug: BI 1703880
BI 1703880

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period
Time Frame: up to 6 weeks
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of DLTs during the on-treatment period
Time Frame: up to 804 days
up to 804 days
Maximum measured concentration of BI 1703880 in plasma (Cmax)
Time Frame: up to 804 days
up to 804 days
Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time Frame: up to 804 days
up to 804 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

January 19, 2023

Primary Completion (Estimated)

January 7, 2025

Study Completion (Estimated)

March 10, 2027

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1480-0001
  • 2022-000298-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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