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Solid Tumors, KRAS MutationPhase 1NCT04973163

A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation

A Phase 1 study testing BI 1823911, BI 1701963 and Midazolam in people with Solid Tumors, KRAS Mutation, run by Boehringer Ingelheim at 9 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is open to adults with different types of advanced or metastatic cancer (including lung cancer, colorectal cancer, pancreatic cancer, and bile duct cancer). This study is for people for whom previous treatment was not successful or no treatment exists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, KRAS Mutation
What is being tested?
BI 1823911, BI 1701963 and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
9 sitesin 4 countries
Study dates
9 Sep 2021to 27 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Pathologically confirmed diagnosis of locally advanced or metastatic solid tumours, e.g. adenocarcinoma of the lung, colorectal cancer, pancreatic cancer or cholangiocarcinoma. Non-small cell lung cancer (NSCLC) patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
  • Documented disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumour type and disease stage.
  • KRAS mutation status: Kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation in tumour tissue or blood based on previously performed local testing using a validated test.
  • Provision of archival tumour tissue, if available, to confirm retrospectively KRAS G12C mutation status and for biomarker assessment.
  • At least one target lesion that can be measured per Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (radiated lesions do not qualify as target lesions). In patients who only have one target lesion, and a biopsy of the lesion is required, the baseline imaging must be performed before the biopsy or at the earliest two weeks after the biopsy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Show all 13Show fewer
  • Adequate organ function as follows:
  • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L (equivalent values: ≥ 1.5 x 10³/μL or ≥ 1500/mm³); hemoglobin ≥9.0 g/dL (equivalent values: ≥ 90 g/L or ≥ 5.6 mmol/L); platelets ≥100 x 10^9/L (equivalent values: ≥ 100 x 10³/μL or ≥ 100 x 10³/mm³) without the use of haematopoietic growth factors.
  • Total bilirubin ≤1.5 times the upper limit of normal (ULN), or ≤4 x ULN for patients who are known to have Gilbert's syndrome.
  • Creatinine ≤1.5 x ULN. If creatinine is >1.5 x ULN, patient is eligible if concurrent creatinine clearance ≥50 mL/min (equivalent value: 0.84mL/s) (measured or calculated by Cockcroft-Gault formula).
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN, for patients with liver metastases ≤5 x ULN.
  • 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 anticancer chemotherapy within 3 weeks of the first administration of trial drug. Previous anticancer hormonal treatment or anticancer immunotherapy within 2 weeks of the first administration of trial drug.
  • Previous treatment with Rat Sarcoma (RAS), Mitogen-activated protein kinase (MAPK) or Son of sevenless 1 (SOS1) targeting agents (only for monotherapy Parts A, B, and C).
  • Radiotherapy within 2 weeks prior to start of treatment, provided recovery from related toxicity.
  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of treatment or planned during the projected course of the trial, e.g. hip replacement.
  • Previous treatment with any investigational agent(s) or targeted treatment within 28 days prior to start of treatment or 5 half-lives, whichever is shorter.
  • Known history of hypersensitivity to any of the excipients of BI 1823911 tablets, or any contraindication to Midazolam (for Monotherapy Part B only).
  • History or presence of cardiovascular abnormalities such as congestive heart failure New York Heart Association (NYHA) classification of ≥3, unstable angina or poorly controlled arrhythmia which are considered clinically relevant by the Investigator. Myocardial infarction within 6 months prior to start of treatment. Uncontrolled hypertension defined as: Blood pressure (BP) measured in a rested and relaxed condition, where systolic BP >=140 mmHg, or diastolic BP >= 90 mmHg, with or without medication.
  • Left ventricular ejection fraction (LVEF) <50%. Further exclusion criteria apply.

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

Belgium4 sites

  • Brussels - HOSP Jules Bordet

    Anderlecht/Brussels-Capital, 1070

  • Universitair Ziekenhuis Antwerpen

    Edegem/Antwerpen, 2650

  • Universitair Ziekenhuis Gent

    Gent/Oost-Vlaanderen, 9000

  • UZ Leuven

    Leuven/Vlaams-Brabant, 3000

Other trials in Belgium

United States3 sites

  • Sarah Cannon Research Institute at Mary Crowley

    Dallas, Texas, 75230

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

Spain1 site

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

United Kingdom1 site

  • The Christie

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: A Phase Ia/Ib, Open-label, Multicentre Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of BI 1823911 as a Monotherapy and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumours Expressing KRAS G12C Mutation

This study is open to adults with different types of advanced or metastatic cancer (including lung cancer, colorectal cancer, pancreatic cancer, and bile duct cancer). This study is for people for whom previous treatment was not successful or no treatment exists.

People who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes tumours grow faster. BI 1823911 and BI 1701963 are medicines that may turn off KRAS, each in a different way. In this study, BI 1823911 is given to people for the first time.

Read more

The purpose of this study is to find the highest dose of BI 1823911 that people can tolerate when taken alone and together with BI 1701963. The most suitable dose is used to find out whether BI 1823911 alone and in combination with BI 1701963 can make tumours shrink.

Participants can stay in the study as long as they benefit from treatment and can tolerate it.

During this time, participants take tablets of BI 1823911 alone or in combination with BI 1701963 once a day. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participant's health.

Being tested
BI 1823911, BI 1701963, Midazolam

What participants receive

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

  • BI 1823911Drug

    BI 1823911

  • BI 1701963Drug

    BI 1701963

  • MidazolamDrug

    Midazolam - only administered in Part B (dose confirmation) of the Monotherapy Arm

Study groups in NCT04973163
Study groupRoleWhat they receive
Monotherapy ArmExperimentalEach arm consists of three parts (dose escalation (A), dose confirmation (B), and dose expansion (C).
Receives: Drug: BI 1823911; Drug: Midazolam
Combination Therapy ArmExperimentalWill be started after confirmation of safety in the Monotherapy Arm. Each arm consists of three parts (dose escalation (A), dose confirmation (B), and dose expansion (C).
Receives: Drug: BI 1823911; Drug: BI 1701963

What is being measured

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

  1. Dose escalation (Part A) - Monotherapy and combination therapy: Number of patients experiencing Dose limiting toxicities (DLTs) during the Maximum tolerated dose (MTD) evaluation period for BI 1823911 in monotherapy and in each combination

    DLTs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: up to 28 days

  2. Dose confirmation (Part B) and expansion (Part C) - Monotherapy and combination therapy: Objective response (OR) defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR)

    BOR is determined according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

    BOR will consider all tumour assessments from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

    Measured: up to 39 months

Secondary outcomes (14)

  1. Dose escalation (Part A) - Monotherapy and combination therapy: Number of patients experiencing DLTs during all treatment cycles for BI 1823911 in monotherapy and in each combination

    Measured: up to 39 months

  2. Dose confirmation (Part B) and expansion (Part C) - Monotherapy and combination therapy: Objective response (OR)

    OR is defined as best overall response (BOR) of complete response (CR) or partial response (PR), both regardless of confirmation.

    BOR is determined according to RECIST version 1.1. BOR will consider all tumour assessments from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

    Measured: up to 39 months

  3. Dose confirmation (Part B) and expansion (Part C) - Monotherapy and combination therapy: Duration of OR

    Duration of OR is defined as the time from first documented CR or PR until disease progression or death (whichever occurs first) among patients with OR.

    Measured: up to 39 months

  4. Dose confirmation (Part B) and expansion (Part C) - Monotherapy and combination therapy: Tumour shrinkage (in millimetres)

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

    Measured: up to 39 months

  5. Dose confirmation (Part B) and expansion (Part C) - Monotherapy and combination therapy: Progression-free survival (PFS) rate

    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: at month 6

  6. All study parts: Number of patients with adverse events during the on-treatment period

    Measured: up to 39 months

  7. All study parts, BI 1823911: Maximum concentration (Cmax)

    Measured: up to 24 hours

  8. All study parts, BI 1823911: Steady state concentration (Css)

    Measured: up to 24 hours

  9. All study parts, BI 1823911: Area under the plasma concentration-time curve from time zero to time t (AUCτ)

    Measured: up to 24 hours

  10. All study parts, BI 1823911: Area under the plasma concentration-time curve at steady state (AUCss)

    Measured: up to 24 hours

  11. All study parts, BI 1701963: Maximum concentration (Cmax)

    Measured: up to 24 hours

  12. All study parts, BI 1701963: Steady state concentration (Css)

    Measured: up to 24 hours

  13. All study parts, BI 1701963: Area under the plasma concentration-time curve from time zero to time t (AUCτ)

    Measured: up to 24 hours

  14. All study parts, BI 1701963: Area under the plasma concentration-time curve at steady state (AUCss)

    Measured: up to 24 hours

Timeline

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

  1. First posted22 Jul 2021
  2. Study start9 Sep 2021
  3. Primary completion29 Nov 2026 (estimated)
  4. Study completion27 Dec 2026 (estimated)

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
Model description
The following parts will be included in this trial: * First: Monotherapy Arm * After confirmation of safety: Combination Therapy Arm Each arm consists of three parts (dose escalation (A), dose confirmation (B), and dose expansion (C)).
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973163
Sponsor's protocol ID
1472-0001
Other IDs
2021-000460-29
Status last verified
Oct 2026
First submitted
14 Jul 2021
Last updated
28 Oct 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 1823911, BI 1701963 and Midazolam in people with Solid Tumors, KRAS Mutation, run by Boehringer Ingelheim at 9 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 13 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Belgium, United States, Spain, United Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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?

Dose escalation (Part A) - Monotherapy and combination therapy: Number of patients experiencing Dose limiting toxicities (DLTs) during the Maximum tolerated dose (MTD) evaluation period for BI 1823911 in monotherapy and in each combination (time frame: up to 28 days). The study lists 2 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 NCT04973163.

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 28 Oct 2026.

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