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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06056024
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Solid Tumor, KRAS Mutation Drug: BI 3706674 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 18, 2023
Estimated Primary Completion Date : May 26, 2027
Estimated Study Completion Date : May 26, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A (Phase Ia): Dose escalation Drug: BI 3706674
BI 3706674
Experimental: Part B (Phase Ib): Dose confirmation Drug: BI 3706674
BI 3706674
Experimental: Part C (Phase Ib): Dose expansion Drug: BI 3706674
BI 3706674


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: up to 3.5 years ]
    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.


Secondary Outcome Measures :
  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 [ Time Frame: up to 3.5 years ]
    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.

  4. Part B: Duration of objective response (DOR) [ Time Frame: up to 3.5 years ]
    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.

  5. Part B: Tumour shrinkage [ Time Frame: up to 3.5 years ]
    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.

  6. Part B: Progression-free survival (PFS) [ Time Frame: up to 3.5 years ]
    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.

  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06056024


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, Arizona
Mayo Clinic-Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Japan
National Cancer Center Hospital East Recruiting
Chiba, Kashiwa, Japan, 277-8577
Contact: Boehringer Ingelheim    0120201230    nippon@bitrialsupport.com   
Japanese Foundation for Cancer Research Recruiting
Tokyo, Koto-ku, Japan, 135-8550
Contact: Boehringer Ingelheim    0120201230    nippon@bitrialsupport.com   
Taiwan
NCKUH Recruiting
Tainan, Taiwan, 704
Contact: Boehringer Ingelheim    0809092098    taiwan@bitrialsupport.com   
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Boehringer Ingelheim    0809092098    taiwan@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT06056024    
Other Study ID Numbers: 1512-0001
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.mystudywindow.com/msw/datatransparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No