Testing a new cancer treatment with BI 1703880 and ezabenlimab

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 testing a new cancer treatment combining two medications to see if they can help adults with advanced tumors that haven’t responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Drugs / interventions: immunotherapy, prednisone, ezabenlimab
• Locations: 13 sites (Los Angeles, California and 12 other locations)
• Trial ID: NCT05471856 on ClinicalTrials.gov

What this trial studies

This study is designed for adults with advanced solid tumors who have not responded to previous treatments or have no available options. It aims to determine the highest tolerable dose of BI 1703880 when combined with ezabenlimab, both of which are intended to enhance the immune system's ability to fight cancer. Participants will receive these medications through intravenous infusions, with a specific schedule for administration over a period of up to two years. Regular health assessments will be conducted to monitor the participants' responses and tolerability to the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced, unresectable solid tumors who have exhausted or are ineligible for standard treatment options.

Not a fit: Patients with early-stage cancer or those who have not yet received standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with advanced cancer who have limited alternatives.

How similar studies have performed: Other studies have shown promise in using immune-modulating therapies for advanced cancers, suggesting potential for success with this approach.

Eligibility criteria

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

Where this trial is running

Los Angeles, California and 12 other locations

• Valkyrie Clinical Trials — Los Angeles, California, United States (Recruiting)
• Yale University School of Medicine — New Haven, Connecticut, United States (Recruiting)
• John Theurer Cancer Center — Hackensack, New Jersey, United States (Recruiting)
• National Cancer Center Hospital East — Chiba, Kashiwa, Japan (Recruiting)
• Saitama Medical University International Medical Center — Saitama, Hidaka, Japan (Not_yet_recruiting)
• Japanese Foundation for Cancer Research — Tokyo, Koto-ku, Japan (Recruiting)
• Hospital Universitari Vall D Hebron — Barcelona, Spain (Recruiting)
• CIO Clara Campal — Madrid, Spain (Recruiting)
• Instituto Valenciano de Oncología — Valencia, Spain (Recruiting)
• Hospital Clinico Universitario De Valencia — Valencia, Spain (Recruiting)
• The Royal Marsden Hospital, Chelsea — London, United Kingdom (Recruiting)
• Churchill Hospital — Oxford, United Kingdom (Recruiting)
• The Royal Marsden Hospital, Sutton — Sutton, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Solid Tumors