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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

Completed Phase 1 Last updated 17 March 2026
What this trial tests

Phase 1 trial testing BI 3706674 in Solid Tumor, KRAS Mutation in 47 participants. Completed in 17 December 2025.

Timeline
6 December 2023
Primary endpoint
17 December 2025
17 December 2025

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment47
Start date6 December 2023
Primary completion17 December 2025
Estimated completion17 December 2025
Sites17 locations across Taiwan, Japan, United States, South Korea

Drugs / interventions tested

Conditions studied

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):

  1. Targeting KRAS in cancer.
    Singhal A, Li BT, O'Reilly EM. · · 2024 · cited 209× · PMID 38637634 · DOI 10.1038/s41591-024-02903-0
  2. 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
  3. 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
  4. 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
  5. "Undruggable KRAS": druggable after all.
    Cox AD, Der CJ. · · 2025 · cited 31× · PMID 39638567 · DOI 10.1101/gad.352081.124
  6. 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
  7. 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
  8. 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

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