Solid TumorsPhase 1NCT05839600
A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer
A Phase 1 study testing BI 1821736 in people with Solid Tumors, run by Boehringer Ingelheim at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BI 1821736
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 7 Jun 2023to 10 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Spain4 sites
Hospital Quiron. I.C.U.
Barcelona, 08023
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitario 12 de Octubre
Madrid, 28041
Instituto Valenciano de Oncología
Valencia, 46009
United States2 sites
Yale Cancer Center
New Haven, Connecticut, 06511
NEXT Oncology-San Antonio-65273
San Antonio, Texas, 78229
About this study
Official title: 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.
- Conditions
- Solid Tumors
- Being tested
- BI 1821736
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1821736Drug
Solution for infusion/injection
| Study group | Role | What they receive |
|---|---|---|
| BI 1821736 low dose | Experimental | Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Receives: Drug: BI 1821736 |
| BI 1821736 high dose | Experimental | Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Receives: Drug: BI 1821736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First treatment cycle, i.e., 21 days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start7 Jun 2023
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839600
- Sponsor's protocol ID
- 1467-0001
- Other IDs
- 2022-502125-17-00, U1111-1291-2873
- Status last verified
- May 2026
- First submitted
- 21 Apr 2023
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Dose Escalation and Expansion Trial to Investigate Safety and Efficacy of BI 1821736 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05839600
- Acronym / sponsor ID
- 1467-0001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1821736 low dose | Experimental | Drug: BI 1821736Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. |
| BI 1821736 high dose | Experimental | Drug: BI 1821736Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1821736Solution for infusion/injection | Drug | BI 1821736 high dose, BI 1821736 low dose |
Primary outcome
Occurrence of DLTs in the MTD Evaluation Period
Time frame: First treatment cycle, i.e., 21 days.
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.
2 secondary outcomes
Occurrence of DLTs During the On-treatment Period
Time frame: 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
Time frame: From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1821736 in people with Solid Tumors, run by Boehringer Ingelheim at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, United States, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of DLTs in the MTD Evaluation Period (time frame: First treatment cycle, i.e., 21 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.