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

Last updated: April 29, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

BI 3706674

Clinical Study ID

NCT06056024
1512-0001
  • Ages > 18
  • All Genders

Study Summary

This study is open to 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with pathologically confirmed diagnosis of locally advanced or metastaticgastric adenocarcinoma (GAC), oesophageal adenocarcinomas (EAC), andgastroesophageal junction adenocarcinoma (GEJAC) with Kirsten rat sarcoma viraloncogene homolog (KRAS) wild type (wt) amplification and documented diseaseprogression despite at least 1 line of prior therapy. KRAS status will be confirmedretrospectively for those with a known KRAS status or determined prospectively (doseconfirmation and expansion) if KRAS status is unknown, using archival tissue (ifavailable) or a fresh biopsy. Dose escalation (Part A) only: Patients with advanced or metastatic relapsed orrefractory solid tumours of any histology with KRAS wt amplification or harbouring aKRAS G12V mutation who have exhausted treatment options known to prolong survivalfor their disease. Detection of KRAS status by a local test is allowed for enrolmentbut will be retrospectively confirmed.

  2. Patients who have failed conventional treatment or for whom no therapy of provenefficacy exists or who are not eligible for established treatment options.

  3. Dose confirmation (Part B) only: Patient is willing and able to undergo mandatorypre- and on-treatment low risk tumour biopsies. Patients with a high risk for biopsycomplications can be included without undergoing pre- and on-treatment tumour biopsyas 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 (radiatedlesions do not qualify as target lesions unless there has been demonstratedprogression 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 ifagreed 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 peripheralneuropathy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders whichcan be any grade).

  7. Life expectancy ≥3 months at the start of treatment in the opinion of theinvestigator.

  8. Age ≥18 years of age, or over the legal age of consent as required by locallegislation.

Further inclusion criteria apply.

Exclusion

Exclusion Criteria:

  1. Previous anti-cancer chemotherapy within 3 weeks of the first administration oftrial drug.

  2. Previous anti-cancer hormonal treatment or anti-cancer immunotherapy within 2 weeksof 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 (definedas systolic blood pressure ≥140 and/or diastolic blood pressure ≥90 millimetre ofmercury (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 monthsprior 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 completedat least 2 weeks prior to randomisation.

  • Single dose palliative radiotherapy for symptomatic metastasis within 2 weeksprior to randomisation may be allowed but must be discussed with the Sponsor.

Further exclusion criteria apply.

Study Design

Total Participants: 146
Treatment Group(s): 1
Primary Treatment: BI 3706674
Phase: 1
Study Start date:
December 06, 2023
Estimated Completion Date:
May 26, 2027

Connect with a study center

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • NCKUH

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Mayo Clinic-Arizona

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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