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Solid Tumor, KRAS MutationPhase 1NCT06056024

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 study testing BI 3706674 in people with Solid Tumor, KRAS Mutation, run by Boehringer Ingelheim at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, KRAS Mutation
What is being tested?
BI 3706674
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
17 sitesin 4 countries
Study dates
6 Dec 2023to 17 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options.
  • 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.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • 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).
  • Life expectancy ≥3 months at the start of treatment in the opinion of the investigator.
  • Age ≥18 years of age, or over the legal age of consent as required by local legislation.
  • Further inclusion criteria apply.

Who cannot join

  • Previous anti-cancer chemotherapy within 3 weeks of the first administration of trial drug.
  • Previous anti-cancer hormonal treatment or anti-cancer immunotherapy within 2 weeks of the first administration of trial drug.
  • Previous treatment with rat sarcoma (RAS), mitogen-activated protein kinases (MAPKs) or son of sevenless homolog 1 (SOS1) targeting agents.
  • 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.
  • Left ventricular ejection fraction (LVEF) <50%.
  • Congenital or family history of long QT prolongation syndrome.
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  • Mean resting corrected QT interval (QTcF) >470 msec.
  • 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.

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

South Korea7 sites

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 137-701

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Yale Cancer Center

    New Haven, Connecticut, 06511

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic-Arizona

    Phoenix, Arizona, 85054

Other trials in United States

Japan2 sites

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

Other trials in Japan

Taiwan2 sites

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Open-label Dose-finding Trial to Explore Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BI 3706674 Given Orally as Monotherapy in Patients With Unresectable Metastatic KRAS Wild Type Amplified Gastric, Oesophageal, and Gastroesophagealjunction Adenocarcinoma

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.

Being tested
BI 3706674

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 3706674Drug

    BI 3706674

Study groups in NCT06056024
Study groupRoleWhat they receive
Part A (Phase Ia): Dose escalationExperimentalNot described
Receives: Drug: BI 3706674
Part B (Phase Ib): Dose confirmationExperimentalNot described
Receives: Drug: BI 3706674
Part C (Phase Ib): Dose expansionExperimentalNot described
Receives: Drug: BI 3706674

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: 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.

    Measured: up to 3.5 years

Secondary outcomes (14)

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

    Measured: up to 3.5 years

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: up to 3.5 years

  7. Part C: Duration of objective response

    Measured: up to 3.5 years

  8. Part C: Tumour shrinkage

    Measured: up to 3.5 years

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

    Measured: up to 3.5 years

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

    Measured: 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

    Measured: up to 28 days

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

    Measured: 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)

    Measured: 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

    Measured: up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start6 Dec 2023
  3. Primary completion17 Dec 2025
  4. Study completion17 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06056024
Sponsor's protocol ID
1512-0001
Status last verified
Mar 2026
First submitted
19 Sep 2023
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 3706674 in people with Solid Tumor, KRAS Mutation, run by Boehringer Ingelheim at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Korea, United States, Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (time frame: up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06056024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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