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NCT04958239
A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
Phase 1 trial testing BI 765179 in Neoplasms in 151 participants. Participants enrolled and being followed up; not accepting new ones.
29 April 2026
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 151 |
| Start date | 18 October 2021 |
| Primary completion | 29 April 2026 |
| Estimated completion | 17 February 2028 |
| Sites | 48 locations across France, Italy, Japan, Netherlands, Belgium, Germany, Israel, Mexico |
Drugs / interventions tested
- BI 765179 — full drug profile →
- Ezabenlimab — full drug profile →
- Pembrolizumab (pembrolizumab) — 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.
Sponsor's own description
This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer. In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein. BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time. Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The emerging landscape of novel 4-1BB (CD137) agonistic drugs for cancer immunotherapy.
Claus C, Ferrara-Koller C, Klein C. · · 2023 · cited 65× · PMID 36727218 · DOI 10.1080/19420862.2023.2167189 -
Tumour-associated macrophages: versatile players in the tumour microenvironment.
Ji ZZ, Chan MK, Chan AS, Leung KT, et al · · 2023 · cited 18× · PMID 37965573 · DOI 10.3389/fcell.2023.1261749 -
Hotspots and frontiers of the relationship between hepatocellular carcinoma and cancer-associated fibroblasts: a bibliometric analysis and review.
Zheng H, Ren L, Chen G, Hu X. · · 2025 · PMID 41420058 · DOI 10.1007/s12672-025-04245-w
Verify or expand the search:
- PubMed search for NCT04958239
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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)
- Trial protocol + status: ClinicalTrials.gov NCT04958239 (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: 14 April 2026
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/NCT04958239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing