An Open-label, Phase I Dose Escalation and Expansion Trial to Investigate Safety and Efficacy of BI 1821736 in Patients With Advanced Solid Tumors

Boehringer Ingelheim7 sites in 4 countries10 target enrollmentJune 7, 2023

ConditionsSolid Tumors

InterventionsBI 1821736

Overview

Phase: Phase 1
Intervention: BI 1821736
Conditions: Solid Tumors
Sponsor: Boehringer Ingelheim
Enrollment: 10
Locations: 7
Primary Endpoint: Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period
Status: Terminated
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is open to adults with advanced solid tumours. People with solid tumours for whom previous treatment was not successful or no treatment exists can take part.

The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type of immunotherapy. It is a special virus that kills cancer cells and helps the immune system fight cancer. In this study, BI 1821736 is given to humans for the first time.

Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1821736.

Registry

clinicaltrials.gov

Start Date

June 7, 2023

End Date

April 10, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed diagnosis of malignant tumor.
•Advanced, unresectable and/or metastatic or relapsed/refractory solid tumors.
•Has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease.
•Has at least one tumoral lesion which is amenable to biopsy.
•Signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation obtained prior to any trial-specific procedures, sampling, or analyses that are not part of normal standard of practice care.
•Eastern Cooperative Oncology Group score of 0 or
•Adequate organ function or bone marrow reserve defined as demonstrated at screening by the following laboratory values:
•Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1.5 x 10\^3/μL)(≥ 1500/mm\^3); haemoglobin ≥ 90 g/L (≥ 9.0 g/dL)(≥ 5.6 mmol/L); platelets ≥ 100 x 10\^9/L (≥ 100 x 10\^3/μL)(≥ 100 x 10\^3/mm\^3) without the use of haematopoietic growth factors within 4 weeks of start of trial medication.
•Creatinine ≤ 1.5 times the upper limit of normal (ULN).
•Total bilirubin ≤ 1.5 times the ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3 times ULN or direct bilirubin ≤ 1.5 times ULN.

Exclusion Criteria

•Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment.
•Previous treatment with Vesicular Stomatitis Virus (VSV)-based agents.
•Patients with brain metastases unless they have completed brain radiotherapy and are asymptomatic.
•Radiotherapy within 4 weeks prior to the start of study treatment, except in case of a brief course of palliative radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture) which can then be completed within two weeks prior to start of study treatment.
•Note: No radiation must have been given to any lesions planned to be biopsied within 6 months of start of treatment.
•Prior (within 3 weeks of first dose) or concomitant use of systemic corticosteroids (\>10 mg daily prednisone or equivalent).
•Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of a medication or a condition considered a high risk for complications from biopsy as per the Investigator's judgement.
•Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of interferon, immunotherapy agents, or tamoxifen.
•Active infection requiring systemic therapy (antibacterial, antiviral, antiparasitic or antifungal therapy) at the start of treatment in the trial.
•Further exclusion criteria apply