NCT04147247 is a Phase 1 clinical trial of BI 905681 in Neoplasms, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT04147247?

NCT04147247 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT04147247?

Interventions in NCT04147247: BI 905681.

Is NCT04147247 still recruiting?

NCT04147247 is currently completed. Last updated 29 November 2023.

Are results published for NCT04147247?

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

Last reviewed 2023-11-29 · How we verify

NCT04147247

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

A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread

Completed Phase 1 Results posted Last updated 29 November 2023

What this trial tests

Phase 1 trial testing BI 905681 in Neoplasms in 21 participants. Completed in 27 May 2021.

Timeline

23 December 2019

Primary endpoint
6 May 2021

27 May 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	23 December 2019
Primary completion	6 May 2021
Estimated completion	27 May 2021
Sites	3 locations across United States

Drugs / interventions tested

BI 905681 — 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.

The Maximum Tolerated Dose (MTD)/Optimal Biological Dose (OBD) of BI 905681 Primary · The first cycle of treatment, up to 21 days.

The MTD/OBD of BI 905681. The MTD will be assessed based on the number of patients experiencing Dose Limiting Toxicities (DLTs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, in the first cycle of treatment (3 weeks). The MTD is defined as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.

Group	Value	95% CI
BI 905681	NA

Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period Primary · From the first administration of study till the last administration of study drug +42 days, up to 126 days.

Number of patients experiencing adverse events (AEs) during the entire treatment period.

Group	Value	95% CI
1.0 Milligram/Kilogram BI 905681	2
2.5 Milligram/Kilogram BI 905681	4
5.0 Milligram/Kilogram BI 905681	5
7.0 Milligram/Kilogram BI 905681	4
8.5 Milligram/Kilogram BI 905681	4

Cmax: Maximum Measured Concentration of BI 905681 in Serum After First Infusion Secondary · 5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.

Cmax: maximum measured concentration of BI 905681 in serum after first infusion.

Group	Value	95% CI
1.0 Milligram/Kilogram BI 905681	NA	± NA
2.5 Milligram/Kilogram BI 905681	49.6	± 19.7
5.0 Milligram/Kilogram BI 905681	157	± 18.0
7.0 Milligram/Kilogram BI 905681	185	± 23.1
8.5 Milligram/Kilogram BI 905681	201	± 21.4

AUC0-tz: Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (tz) Secondary · 5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.

AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz).

Group	Value	95% CI
1.0 Milligram/Kilogram BI 905681	4260	± 27.8
2.5 Milligram/Kilogram BI 905681	7640	± 10.6
5.0 Milligram/Kilogram BI 905681	18200	± 53.2
7.0 Milligram/Kilogram BI 905681	30000	± 23.8
8.5 Milligram/Kilogram BI 905681	18900	± 217

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

1.0 Milligram/Kilogram BI 905681

Serious: 1/3 (33%)

Deaths: 0/3

2.5 Milligram/Kilogram BI 905681

Serious: 1/4 (25%)

Deaths: 1/4

5.0 Milligram/Kilogram BI 905681

Serious: 2/5 (40%)

Deaths: 2/5

7.0 Milligram/Kilogram BI 905681

Serious: 1/4 (25%)

Deaths: 0/4

8.5 Milligram/Kilogram BI 905681

Serious: 0/5 (0%)

Deaths: 0/5

Serious adverse events (11 terms)

Reaction	System	1.0 Milligram/Kilogram BI …	2.5 Milligram/Kilogram BI …	5.0 Milligram/Kilogram BI …	7.0 Milligram/Kilogram BI …	8.5 Milligram/Kilogram BI …
Myocardial infarction	Cardiac disorders	—	—	—	—	—
Abdominal hernia obstructive	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Klebsiella bacteraemia	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Hypophagia	Metabolism and nutrition disorders	—	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—
Embolism	Vascular disorders	—	—	—	—	—

Other adverse events (43 terms — click to expand)

Reaction	System	1.0 Milligram/Kilogram BI …	2.5 Milligram/Kilogram BI …	5.0 Milligram/Kilogram BI …	7.0 Milligram/Kilogram BI …	8.5 Milligram/Kilogram BI …
Constipation	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Duodenal stenosis	Gastrointestinal disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Suprapubic pain	General disorders	—	—	—	—	—
Cholestasis	Hepatobiliary disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
C-telopeptide increased	Investigations	—	—	—	—	—
Troponin I increased	Investigations	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Encephalopathy	Nervous system disorders	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—
Oedema genital	Reproductive system and breast disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Most-reported serious reactions: Myocardial infarction, Abdominal hernia obstructive, Abdominal pain, Ascites, Fatigue, Klebsiella bacteraemia, Sepsis, Hypophagia.

Data from ClinicalTrials.gov NCT04147247 adverse events section.

Sponsor's own description

The primary objective of this trial is to determine the maximum tolerated dose (MTD)/optimal biological dose (OBD) of BI 905681 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905681. The MTD will be defined based on the frequency of patients experiencing dose-limiting toxicities (DLTs) during the MTD/DLT evaluation period, which is defined as the first cycle of treatment. Separate MTDs will be determined for Schedule A and Schedule B. The secondary objective of the trial is to determine the pharmacokinetic (PK) profile of BI 905681.

Publications & conference data

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

Natural compounds: Wnt pathway inhibitors with therapeutic potential in lung cancer.
Shen X, Gao C, Li H, Liu C, et al · · 2023 · cited 12× · PMID 37841927 · DOI 10.3389/fphar.2023.1250893
A phase I dose escalation study of the LRP5 antagonist BI 905681 in patients with advanced and metastatic solid tumors.
Spigel DR, Wang JS, Pronk L, Muskens B, et al · · 2024 · cited 3× · PMID 39617535 · DOI 10.1016/j.esmoop.2024.103730

Verify or expand the search:

Other recruiting trials for Neoplasms

Currently open trials in the same condition.

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

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 NCT04147247 (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: 29 November 2023

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/NCT04147247.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing