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NCT06056024
A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in the Stomach and Oesophagus
Phase 1 trial testing BI 3706674 in Solid Tumor, KRAS Mutation in 47 participants. Completed in 17 December 2025.
17 December 2025
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 | 47 |
| Start date | 6 December 2023 |
| Primary completion | 17 December 2025 |
| Estimated completion | 17 December 2025 |
| Sites | 17 locations across Taiwan, Japan, United States, South Korea |
Drugs / interventions tested
- BI 3706674 — full drug profile →
Conditions studied
- Solid Tumor, KRAS Mutation — all drugs for Solid Tumor, KRAS Mutation →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
18 and older, any sex, with Solid Tumor, KRAS Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is no longer open to new participants. It was a study in adults with advanced cancer in the stomach and oesophagus. This is a study for people for whom previous treatment was not successful or no treatment exists. In this study, BI 3706674 is given to humans for the first time. The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone. Another purpose is to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing. Participants take BI 3706674 as a tablet when starting treatment. Different doses of BI 3706674 are tested during this study. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting KRAS in cancer.
Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0 -
Consensus, debate, and prospective on pancreatic cancer treatments.
Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x -
RAS signaling in carcinogenesis, cancer therapy and resistance mechanisms.
Yang X, Wu H. · · 2024 · cited 53× · PMID 39522047 · DOI 10.1186/s13045-024-01631-9 -
Targeting KRAS: from metabolic regulation to cancer treatment.
Shi Y, Zheng H, Wang T, Zhou S, et al · · 2025 · cited 37× · PMID 39799325 · DOI 10.1186/s12943-024-02216-3 -
"Undruggable KRAS": druggable after all.
Cox AD, Der CJ. · · 2025 · cited 31× · PMID 39638567 · DOI 10.1101/gad.352081.124 -
Digestive cancers: mechanisms, therapeutics and management.
Zhan T, Betge J, Schulte N, Dreikhausen L, et al · · 2025 · cited 30× · PMID 39809756 · DOI 10.1038/s41392-024-02097-4 -
Pan-KRAS Inhibitors BI-2493 and BI-2865 Display Potent Antitumor Activity in Tumors with KRAS Wild-type Allele Amplification.
Tedeschi A, Schischlik F, Rocchetti F, Popow J, et al · · 2025 · cited 17× · PMID 39711431 · DOI 10.1158/1535-7163.mct-24-0386 -
Response and Resistance to RAS Inhibition in Cancer.
Ebright RY, Dilly J, Shaw AT, Aguirre AJ. · · 2025 · cited 16× · PMID 40293709 · DOI 10.1158/2159-8290.cd-25-0349
Verify or expand the search:
- PubMed search for NCT06056024
- 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 NCT06056024 (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: 17 March 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/NCT06056024.
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