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CompletedNCT06056024Updated Mar 17, 2026

A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in the Stomach and Oesophagus

A Phase 1 interventional study of BI 3706674 in Solid Tumor, KRAS Mutation, sponsored by Boehringer Ingelheim. Completed at 17 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Solid Tumor, KRAS Mutation
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with pathologically confirmed diagnosis of locally advanced or metastatic gastric adenocarcinoma (GAC), oesophageal adenocarcinomas (EAC), and gastroesophageal junction adenocarcinoma (GEJAC) with Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) amplification and documented disease progression despite at least 1 line of prior therapy. KRAS status will be confirmed retrospectively for those with a known KRAS status or determined prospectively (dose confirmation and expansion) if KRAS status is unknown, using archival tissue (if available) or a fresh biopsy.

    Dose escalation (Part A) only: Patients with advanced or metastatic relapsed or refractory solid tumours of any histology with KRAS wt amplification or harbouring a KRAS G12V mutation who have exhausted treatment options known to prolong survival for their disease. Detection of KRAS status by a local test is allowed for enrolment but will be retrospectively confirmed.

  2. Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options.
  3. Dose confirmation (Part B) only: Patient is willing and able to undergo mandatory pre- and on-treatment low risk tumour biopsies. Patients with a high risk for biopsy complications can be included without undergoing pre- and on-treatment tumour biopsy as long as archival tumour tissue is available for confirmation of KRAS status.
  4. At least one target lesion that can be measured per RECIST version 1.1 (radiated lesions do not qualify as target lesions unless there has been demonstrated progression of the lesion after completion of radiotherapy) Dose escalation (Part A) only: Patients with no lesions measurable per RECIST version 1.1 may be included if agreed between Sponsor and investigator.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. All toxicities related to previous anti-cancer therapies have resolved ≤ CTCAE Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
  7. Life expectancy ≥3 months at the start of treatment in the opinion of the investigator.
  8. Age ≥18 years of age, or over the legal age of consent as required by local legislation.

Further inclusion criteria apply.

Exclusion criteria

Exclusion Criteria:

  1. Previous anti-cancer chemotherapy within 3 weeks of the first administration of trial drug.
  2. Previous anti-cancer hormonal treatment or anti-cancer immunotherapy within 2 weeks of the first administration of trial drug.
  3. Previous treatment with rat sarcoma (RAS), mitogen-activated protein kinases (MAPKs) or son of sevenless homolog 1 (SOS1) targeting agents.
  4. Presence of cardiovascular abnormalities such as uncontrolled hypertension (defined as systolic blood pressure ≥140 and/or diastolic blood pressure ≥90 millimetre of mercury (mmHg)), congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia. History of myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomisation.
  5. Left ventricular ejection fraction (LVEF) \<50%.
  6. Congenital or family history of long QT prolongation syndrome.
  7. Mean resting corrected QT interval (QTcF) >470 msec.

  8. Radiotherapy within 2 weeks prior to start of treatment, except as follows:

    • Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior to randomisation.
    • Single dose palliative radiotherapy for symptomatic metastasis within 2 weeks prior to randomisation may be allowed but must be discussed with the Sponsor.

Further exclusion criteria apply.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Part A (Phase Ia): Dose escalation

    Drug: BI 3706674

  • Experimental
    Part B (Phase Ib): Dose confirmation

    Drug: BI 3706674

  • Experimental
    Part C (Phase Ib): Dose expansion

    Drug: BI 3706674

Interventions

  • DrugBI 3706674

    BI 3706674

06

What researchers measure

Primary outcomes

  1. Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

    Time frame: up to 28 days

  2. Part B: Occurrence of drug-related adverse events (AEs) ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 during the on-treatment period

    Time frame: up to 3.5 years

  3. Part C: Objective response (OR) based on central assessment

    OR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.

    Time frame: up to 3.5 years

Secondary outcomes

  1. Part A: Occurrence of DLTs during the on-treatment period

    Time frame: up to 3.5 years

  2. Part B: Occurrence of DLTs during the on-treatment period

    Time frame: up to 3.5 years

  3. Part B: OR based on central assessment

    OR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.

    Time frame: up to 3.5 years

  4. Part B: Duration of objective response (DOR)

    DOR is defined as the time from first documented CR or PR until the earliest of disease progression or death among patients with objective response.

    Time frame: up to 3.5 years

  5. Part B: Tumour shrinkage

    Tumour shrinkage is defined as the difference between the minimum post-baseline sum of diameters of target lesions (long axis for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions.

    Time frame: up to 3.5 years

  6. Part B: Progression-free survival (PFS)

    PFS is defined as the time from first treatment administration until tumour progression according to RECIST version 1.1 or death from any cause, whichever occurs earlier.

    Time frame: up to 3.5 years

  7. Part C: Duration of objective response

    Time frame: up to 3.5 years

  8. Part C: Tumour shrinkage

    Time frame: up to 3.5 years

  9. Part C: Progression-free survival (PFS)

    Time frame: up to 3.5 years

  10. All trial parts: Maximum measured concentration (Cmax) of BI 3706674 evaluated after the first dose in Cycle 1

    Time frame: up to 28 days

  11. All trial parts: Area under the plasma concentration-time curve over a uniform dosing interval τ (AUCτ) of BI 3706674 evaluated after the first dose in Cycle 1

    Time frame: up to 28 days

  12. Maximum measured concentration of BI 3706674 evaluated at steady state on Cycle 2 Day 1 (Cmax,ss)

    Time frame: From Day 1 of Cycle 2 (each cycle is 28 days) up to 3.5 years

  13. All trial parts: Area under the plasma concentration-time curve over a uniform dosing interval τ of BI 3706674 evaluated at steady state on Cycle 2 Day 1 (AUCτ,ss)

    Time frame: From Day 1 of Cycle 2 (each cycle is 28 days) up to 3.5 years

  14. All trial parts: Occurrence of AEs during the on-treatment period

    Time frame: up to 3.5 years

07

Study locations

17 sites
  • Mayo Clinic-Arizona
    Phoenix, Arizona 85054, United States
  • Yale Cancer Center
    New Haven, Connecticut 06511, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • National Cancer Center Hospital East
    Chiba, Kashiwa, 277-8577, Japan
  • Japanese Foundation for Cancer Research
    Tokyo, Koto-ku, 135-8550, Japan
  • Seoul National University Bundang Hospital
    Seongnam, 13620, South Korea
  • Seoul National University Hospital
    Seoul, 03080, South Korea
  • Severance Hospital
    Seoul, 03722, South Korea
  • Asan Medical Center
    Seoul, 05505, South Korea
  • Samsung Medical Center
    Seoul, 135-710, South Korea
  • The Catholic University of Korea, Seoul St.Mary's Hospital
    Seoul, 137-701, South Korea
  • Ajou University Hospital
    Suwon, 16499, South Korea
  • NCKUH
    Tainan, 704, Taiwan
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

References and documents

Related links

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06056024
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Dec 6, 2023
Primary completion
Dec 17, 2025
Completion
Dec 17, 2025
Last update
Mar 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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