Cancer-Killing virus tested in humans for first time
NCT ID NCT05839600
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a new immunotherapy called BI 1821736 in 10 adults with advanced solid tumors that had not responded to standard treatments. BI 1821736 is a specially designed virus meant to kill cancer cells and help the immune system fight the cancer. Participants received the drug every 3 weeks for up to 3 months, and doctors monitored safety and tumor response. The study was terminated early, so only limited safety and dosing information is available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 1821736 (a virus that kills cancer cells and boosts the immune system)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This was a very early, small trial (10 people) that was terminated, so results are limited. The virus may cause side effects or not shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Apr 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Clínic de Barcelona
Barcelona, 08036, Spain
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Hospital Quiron. I.C.U.
Barcelona, 08023, Spain
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Instituto Valenciano de Oncología
Valencia, 46009, Spain
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Karolinska Universitetssjukhuset Stockholm
Stockholm, 17177, Sweden
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NEXT Oncology-San Antonio-65273
San Antonio, Texas, 78229, United States
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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Yale Cancer Center
New Haven, Connecticut, 06511, United States
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- New injectable drug tested for safety in Hard-to-Treat solid tumors
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