A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: BI 1821736

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08023
    • Hospital Quiron. I.C.U.
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Universitetssjukhuset Stockholm
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology-San Antonio-65273

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 1.

• 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.
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
  • Partial thromboplastin (PT) / activated partial thromboplastin time (aPTT) <1.5 times ULN unless on a stable dose of an anticoagulant.
  • All toxicities related to previous anti-cancer therapies have resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
• Further inclusion criteria apply

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 1821736 low dose; Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.	Drug: BI 1821736; Solution for infusion/injection
Experimental: BI 1821736 high dose; Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.	Drug: BI 1821736; Solution for infusion/injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of DLTs in the MTD Evaluation Period	Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period is reported as count of participants with DLTs in the MTD evaluation period.	First treatment cycle, i.e., 21 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of DLTs During the On-treatment Period	Occurrence of DLTs during the on-treatment period is reported as count of participants with DLTs during the on-treatment period.	From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Occurrence of AEs During the On-treatment Period	Occurrence of adverse events (AEs) during the on-treatment period is reported as count of participants with AEs during the on-treatment period.	From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1467-0001; 2022-502125-17-00 (Registry Identifier: CTIS (EU)); U1111-1291-2873 (Registry Identifier: WHO Registry)

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:

URL: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No