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
Details
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.
Eligibility
You can join if...
Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; your study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study.
Inclusion Requirements
You can participate in this study if you
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
Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2)
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.
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.
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.
Exclusion Requirements
You cannot participate in this study if you
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.
Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication
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 strong Cytochrome P450 3A4 (CYP3A4) inhibitors
Treatment with strong Cytochrome P450 3A (CYP3A) inducers Further exclusion criteria apply