An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations

  • End date
    Dec 31, 2025
  • participants needed
  • sponsor
    Boehringer Ingelheim
Updated on 25 October 2022
systemic therapy
measurable disease
growth factor
lung cancer
glomerular filtration rate
neutrophil count
epidermal growth factor receptor
brain metastases
targeted therapy
epidermal growth factor
lung carcinoma
egfr t790m


The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.

The purpose of the first study part is to find the highest dose of a medicine called BI 1810631 the participants can tolerate. Once this dose is found, it will be used in the second study part to tests whether BI 1810631 can make tumours shrink.

In this study, BI 1810631 is given to people for the first time. Participants take BI 1810631 as tablets once a day or twice a day.

The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1810631.

Condition Neoplasm Metastasis, Non-Small Cell Lung Cancer
Treatment BI 1810631
Clinical Study IdentifierNCT04886804
SponsorBoehringer Ingelheim
Last Modified on25 October 2022


Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Eastern Cooperative Oncology Group score of 0 or 1
Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment
Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed)
Adequate organ function defined as all of the following
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1.5 x 103/μL) (≥ 1500/mm3); haemoglobin ≥ 9.0 g/dL (≥ 90 g/L) (≥ 5.6 mmol/L); platelets ≥ 100 x 109/L (100 x 103/μL) (100 x 103/mm3) without the use of hematopoietic growth factors within 4 weeks of start of trial medication
Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN
Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min - calculated using Chronic Kidney Disease Epidemiology (CKD-EPI) formula
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases
Alkaline Phosphatase < 5 x ULN
Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria
for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia
Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator
At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years
stable sensory neuropathy and hypothyroidism (patients on thyroid replacement
Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
therapy) which must be ≤ CTCAE Grade 2)
Male or female patients. Women of childbearing potential (WOCBP)1 and men who are able to father a child must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Patients with a documented diagnosis of HER2 aberration: overexpression OR gene amplification OR non-synonymous somatic mutation OR gene rearrangement involving HER2 or Neuregulin 1 (NRG1)
Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted, or not be a suitable candidate for, available treatment options known to prolong survival for their disease
Additional inclusion criteria for Phase Ia
Additional inclusion criteria for Phase Ib - Cohort 1 only
Non-small cell lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation
Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care
Additional inclusion criteria for Phase Ib - Cohort 2 only
NSCLC Patient with a documented HER2 mutation
Treatment naïve for NSCLC
Additional inclusion criteria for Phase Ib - Cohort 3 only
NSCLC Patient with a documented HER2 mutation
Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care

Exclusion Criteria

Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening
Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except
effectively treated non-melanoma skin cancers
effectively treated carcinoma in situ of the cervix
effectively treated ductal carcinoma in situ
other effectively treated malignancy that is considered cured by local treatment
Patients who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial
Use of concomitant medications that are narrow therapeutic index drugs that are substrates of P-Glycoprotein (P-gp) or Breast Cancer Resistance Protein (BCRP) (e.g. digoxin, dabigatran etexilate)
Treatment with a systemic anti-cancer therapy or investigational drug within 21 days
Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors
or 5 half-lives (whichever is shorter) of the first treatment with the study
Treatment with strong Cytochrome P450 3A (CYP3A) inducers
Treatment with Proton Pump Inhibitors (PPIs) or Potassium-competitive acid blockers (PCAB). Patients on these therapies may switch to antiacid or H2antagonists at the discretion of the investigator
Further exclusion criteria apply
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