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About
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 zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.
In this study, zongertinib is given to people for the first time. Participants take zongertinib 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 zongertinib.
Enrollment
Sex
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Volunteers
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 (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6 and 7) .
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:
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.
Additional inclusion criteria for Phase Ia
Additional inclusion criteria for Phase Ib - Cohort 1 only
Additional inclusion criteria for Phase Ib - Cohort 2 only
Additional inclusion criteria for Phase Ib - Cohort 3 only
Additional inclusion criteria for Phase Ib - Cohort 4 only
Additional inclusion criteria for Phase Ib - Cohort 5 only
Additional inclusion criteria for Phase Ib - Cohort 6 only
Additional inclusion criteria for Phase Ib - Cohort 7 only
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;
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
Previous treatment with zongertinib. For Phase Ib only: Previous treatment with any HER2 targeted treatment.
Radiotherapy within 2 weeks prior to first study treatment, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week prior to first study treatment.
Further exclusion criteria apply
Primary purpose
Allocation
Interventional model
Masking
554 participants in 8 patient groups
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Central trial contact
Boehringer Ingelheim; Additional US locations available on demand. Please contact for options.
Data sourced from clinicaltrials.gov
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