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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2025-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor, KRAS Mutation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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United States Japan South Korea Taiwan

Other Identifiers

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1512-0001

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Part A (Phase Ia): Dose escalation

BI 3706674

Part B (Phase Ib): Dose confirmation

BI 3706674

Part C (Phase Ib): Dose expansion

BI 3706674

Interventions

BI 3706674

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boehringer Ingelheim

Responsible Party

Locations

Mayo Clinic-Arizona

Yale Cancer Center

Massachusetts General Hospital

Memorial Sloan-Kettering Cancer Center

University of Pennsylvania

The University of Texas MD Anderson Cancer Center

National Cancer Center Hospital East

Japanese Foundation for Cancer Research

Seoul National University Bundang Hospital

Seoul National University Hospital

Severance Hospital

Asan Medical Center

Samsung Medical Center

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

Ajou University Hospital

NCKUH

National Taiwan University Hospital

Countries

Related Links

Other Identifiers

1512-0001