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)

NCT05471856 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 1480-00012022-000298-22U1111-1303-53592024-511501-37-00
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 13

Brief Summary

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period

  up to 6 weeks

Secondary Outcomes (3)

• Occurrence of DLTs during the on-treatment period

  up to 804 days

• Maximum measured concentration of BI 1703880 in plasma (Cmax)

  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)

  up to 804 days

Study Arms (1)

BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)

EXPERIMENTAL

Drug: BI 1703880; Drug: Ezabenlimab

Interventions

BI 1703880 DRUG

BI 1703880

BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)

Ezabenlimab DRUG

Ezabenlimab

Also known as: BI 754091

BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

RECRUITING

Saitama Medical University International Medical Center

Saitama, Hidaka, 350-1298, Japan

NOT YET RECRUITING

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550, Japan

RECRUITING

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

CIO Clara Campal

Madrid, 28050, Spain

RECRUITING

Instituto Valenciano de Oncología

Valencia, 46009, Spain

RECRUITING

Hospital Clinico Universitario De Valencia

Valencia, 46010, Spain

RECRUITING

The Royal Marsden Hospital, Chelsea

London, SW3 6JJ, United Kingdom

RECRUITING

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

RECRUITING

The Royal Marsden Hospital, Sutton

Sutton, SM2 5PT, United Kingdom

RECRUITING

Related Publications (1)

• Harrington K, Kitano S, Gambardella V, Parkes EE, Moreno I, Alonso G, Doi T, Berz D, Gutierrez ME, Fernandez N, Schmohl M, Barrueco J, LoRusso P. Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors. Future Oncol. 2025 Jan;21(2):195-200. doi: 10.1080/14796694.2024.2441107. Epub 2025 Jan 16.

  PMID: 39817655 DERIVED

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: February 24, 2023
• Primary Completion (Estimated): September 13, 2028
• Study Completion (Estimated): September 13, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); US (3); JP (3); GB (3)