NCT04147234 is a Phase 1 clinical trial of BI 1387446 50 μg in Neoplasms, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT04147234?

NCT04147234 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT04147234?

Interventions in NCT04147234: BI 1387446 50 μg, BI 754091, BI 1387446 100 μg, BI 1387446 200 μg, BI 1387446 400 μg.

Is NCT04147234 still recruiting?

NCT04147234 is currently completed. Last updated 19 August 2025.

Are results published for NCT04147234?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-08-19 · How we verify

NCT04147234

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)

Completed Phase 1 Results posted Last updated 19 August 2025

What this trial tests

Phase 1 trial testing BI 1387446 50 μg in Neoplasms in 42 participants. Completed in 21 March 2024.

Timeline

3 August 2020

Primary endpoint
15 November 2022

21 March 2024

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	3 August 2020
Primary completion	15 November 2022
Estimated completion	21 March 2024
Sites	8 locations across United Kingdom, United States, Spain

Drugs / interventions tested

BI 1387446 50 μg — full drug profile →
BI 754091 — full drug profile →
BI 1387446 100 μg — full drug profile →
BI 1387446 200 μg — full drug profile →
BI 1387446 400 μg — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) Secondary · From start of treatment up to the earliest of progression, death or end of trial (up to 1 year).

Objective response, as defined by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1), in accordance with Clinical Trial Protocol (CTP) Version 1 and 2, will be presented in terms of the objective response rate (ORR). The ORR is the proportion of patients whose best overall response is a confirmed complete response (CR) or partial response (PR). This determination is based on the investigator's assessment according to RECIST 1.1 criteria, from the date of the first treatment administration until the earliest occurrence of any of the following events: disease progression,

Group	Value	95% CI
Arm A: BI 1387446 50 μg	0	0 – 0
Arm A: BI 1387446 100 μg	0	0 – 0
Arm A: BI 1387446 200 μg	0	0 – 0
Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg	0	0 – 0
Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg	0	0 – 0

Objective Response Based on Response Criteria for Intratumoural Immunotherapy in Solid Tumours (itRECIST) Secondary · From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).

Objective Response based on Response Criteria for Intratumoural Immunotherapy in Solid Tumours (itRECIST): (CTP version 3 and later) Objective response (OR) by itRECIST will be presented in terms of objective response rate (ORR), which is defined as the rate of patients whose best overall response is confirmed itCR or itPR as determined by the Investigator's assessment according to itRECIST from date of first treatment administration until the earliest of confirmed disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or

Group	Value	95% CI
Arm A: BI 1387446 200 μg	0	0 – 0
Arm A: BI 1387446 400 μg	1	0.6 – 80.6
Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg	0	0 – 0
Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg	1	0.6 – 80.6

Best Percentage Change From Baseline in Size of Injected Lesions (CTP Version 1 or 2) Secondary · From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of injected lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of injected lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP v1 and v2 using RECIST 1.1), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. Cross-over patien

Group	Value	95% CI
Arm A: BI 1387446 50 μg	23.36	± 28.94
Arm A: BI 1387446 100 μg	-20.73	± 21.95
Arm A: BI 1387446 200 μg	-2.78	± 3.93
Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg	0.54	± 19.24
Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg	13.33	± 18.86

Best Percentage Change From Baseline in Size of Injected Target Lesions (CTP v3.0 or Later Versions) Secondary · From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of injected target lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of injected target lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP version 3 and later using itRECIST), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of conse

Group	Value	95% CI
Arm A: BI 1387446 200 μg	-6.67	± 11.66
Arm A: BI 1387446 400 μg	-37.76	± 52.67
Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg	-17.43	± 39.39
Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg	-16.93	± 58.42

Best Percentage Change From Baseline in Size of Target Lesions (CTP Version 1 or 2) Secondary · From start of treatment until the earliest of progression, death or end of trial (approximately 1 year).

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of target lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of target lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP v1 and v2 using RECIST 1.1), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. Cross-over patients a

Group	Value	95% CI
Arm A: BI 1387446 50 μg	-0.07	± 13.92
Arm A: BI 1387446 100 μg	1.02	± 6.89
Arm A: BI 1387446 200 μg	-0.10	± 7.58
Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg	0.07	± 13.98
Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg	0.25	± 0.36

Maximum Tolerated Dose (MTD) Based on Number of Dose-limiting Toxicities (DLTs) Primary · From first administration of BI 1387446 until to end of treatment cycle 1 (up to 3 weeks).

The MTD in each arm is defined as the highest dose that is expected to cause less than 25% risk of the true DLT rate being above or equal to 33% during the MTD evaluation period. Estimation of the MTD will be based upon the estimation of the posterior probability of the incidence of DLT in toxicity categories during the MTD evaluation period for all evaluable participants. The MTD evaluation period is defined as the time from the first administration of any trial medication to the start of the second treatment cycle. Specifically, this is the time from the first dose to either the second adm

Group	Value	95% CI
Arm A: BI 1387446	NA
Arm B: BI 1387446 + Ezabenlimab	NA

Number of Patients With DLT in the MTD Evaluation Period Primary · From first administration of BI 1387446 until to end of treatment cycle 1 (up to 3 weeks).

The MTD evaluation period is defined as the time from the first administration of any trial medication to the start of the second treatment cycle. Specifically, this is the time from the first dose to either the second administration of ezabenlimab or the fourth administration of BI 1387446, whichever occurs first. If the second dose of ezabenlimab or the fourth dose of BI 1387446 is not given, the evaluation period ends 90 days after the last administration.

Group	Value	95% CI
Arm A: BI 1387446 50 μg	0
Arm A: BI 1387446 100 μg	0
Arm A: BI 1387446 200 μg	1
Arm A: BI 1387446 400 μg	0
Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg	0
Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg	0
Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg	0

Best Percentage Change From Baseline in Size of Non-injected Target Lesions (CTP v3.0 or Later Versions) Secondary · From start of treatment until the earliest of progression, death or end of trial (approximately 1 year).

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of non-injected target lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of non-injected target lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP version 3 and later using itRECIST), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal

Group	Value	95% CI
Arm A: BI 1387446 200 μg	-6.23	± 6.23
Arm A: BI 1387446 400 μg	1.30	± 22.35
Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg	13.42	± 14.14
Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg	-17.28	± 25.17

Adverse events — posted to ClinicalTrials.gov

Time frame: AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 1387446 50 ug

Serious: 2/7 (29%)

Deaths: 1/7

BI 1387446 100 ug

Serious: 4/8 (50%)

Deaths: 2/8

BI 1387446 200 ug

Serious: 3/7 (43%)

Deaths: 2/7

BI 1387446 400 ug

Serious: 0/4 (0%)

Deaths: 1/4

BI 1387446 50 ug / Ezabenlimab 240 mg

Serious: 5/7 (71%)

Deaths: 2/7

BI 1387446 100 ug / Ezabenlimab 240 mg

Serious: 2/5 (40%)

Deaths: 1/5

BI 1387446 200 ug / Ezabenlimab 240 mg

Serious: 2/4 (50%)

Deaths: 1/4

Serious adverse events (21 terms)

Reaction	System	BI 1387446 50 ug	BI 1387446 100 ug	BI 1387446 200 ug	BI 1387446 400 ug	BI 1387446 50 ug / Ezabenl…	BI 1387446 100 ug / Ezaben…	BI 1387446 200 ug / Ezaben…
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Splenic vein thrombosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—
Liver disorder	Hepatobiliary disorders	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—
Injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Hypovolaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Carotid artery stenosis	Nervous system disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—
Device occlusion	Product Issues	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Stridor	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—	—	—	—

Other adverse events (120 terms — click to expand)

Reaction	System	BI 1387446 50 ug	BI 1387446 100 ug	BI 1387446 200 ug	BI 1387446 400 ug	BI 1387446 50 ug / Ezabenl…	BI 1387446 100 ug / Ezaben…	BI 1387446 200 ug / Ezaben…
Fatigue	General disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—	—	—
Cerumen impaction	Ear and labyrinth disorders	—	—	—	—	—	—	—
Hyperthyroidism	Endocrine disorders	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—
Haemorrhoidal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—
Subileus	Gastrointestinal disorders	—	—	—	—	—	—	—
Axillary pain	General disorders	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—
Face oedema	General disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Splenic vein thrombosis, Intestinal obstruction, Liver disorder, Pneumonia, Sepsis, Injury, Hypercalcaemia.

Data from ClinicalTrials.gov NCT04147234 adverse events section.

Sponsor's own description

This is a study in adults with advanced cancer (solid tumours) in whom previous treatment was not successful. The study tests 2 medicines called BI 1387446 and BI 754091. Both medicines may help the immune system fight cancer. In this study, BI 1387446 is given to humans for the first time. The purpose of this study is to find out the highest dose of BI 1387446 alone and in combination with BI 754091 the participants can tolerate. BI 1387446 is injected directly into the tumour. Participants get BI 1387446 injections every week at the beginning and then every 3 weeks. Some participants get BI 754091 in addition to BI 1387446. BI 754091 is given as an infusion into a vein every 3 weeks. As long as they benefit from treatment and can tolerate it, participants can stay in the study for up to 2 years and 8 months. During this time, they visit the study site regularly. At these visit, doctors record any unwanted effects. The doctors also regularly check participants' health.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

STING Agonists as Cancer Therapeutics.
Amouzegar A, Chelvanambi M, Filderman JN, Storkus WJ, et al · · 2021 · cited 311× · PMID 34070756 · DOI 10.3390/cancers13112695
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
Chemical and Biomolecular Strategies for STING Pathway Activation in Cancer Immunotherapy.
Garland KM, Sheehy TL, Wilson JT. · · 2022 · cited 250× · PMID 35107989 · DOI 10.1021/acs.chemrev.1c00750
Exploiting innate immunity for cancer immunotherapy.
Yi M, Li T, Niu M, Mei Q, et al · · 2023 · cited 151× · PMID 38008741 · DOI 10.1186/s12943-023-01885-w
Harnessing innate immune pathways for therapeutic advancement in cancer.
Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
Multifaceted functions of STING in human health and disease: from molecular mechanism to targeted strategy.
Zhang Z, Zhou H, Ouyang X, Dong Y, et al · · 2022 · cited 127× · PMID 36550103 · DOI 10.1038/s41392-022-01252-z
The Development of STING Agonists and Emerging Results as a Cancer Immunotherapy.
Hines JB, Kacew AJ, Sweis RF. · · 2023 · cited 92× · PMID 36705879 · DOI 10.1007/s11912-023-01361-0
STING as an emerging therapeutic target for drug discovery: Perspectives from the global patent landscape.
Kong X, Zuo H, Huang HD, Zhang Q, et al · · 2023 · cited 65× · PMID 35636721 · DOI 10.1016/j.jare.2022.05.006

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04147234 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 19 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04147234.

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