This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group. During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
768
Zongertinib
Trastuzumab deruxtecan
Trastuzumab emtansine
Herceptin®
Xeloda®
mFOLFOX6
zanidatamab
Mayo Clinic-Arizona
Phoenix, Arizona, United States
NOT_YET_RECRUITINGThe Oncology Institute of Hope and Innovation
Cerritos, California, United States
NOT_YET_RECRUITINGEllison Medical Institute
Los Angeles, California, United States
NOT_YET_RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGDose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, and O. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N.
Time frame: up to 21 days
Dose optimization and justification (Phase II): Objective response (OR)
Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review.
Time frame: up to 50 months
Dose escalation (Phase Ib): Objective response (OR)
Time frame: up to 50 months
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period
Time frame: up to 50 months
Dose escalation (Phase Ib): Maximum measured concentration of zongertinib (at steady state) (Cmax,(ss))
For cycle 2 only.
Time frame: up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to 4h at steady state (AUC0-4h,ss)
For cycle 2 only.
Time frame: up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
For cycle 2 only.
Time frame: up to 2 days
Dose optimization and justification (Phase II): Progression-free survival (PFS)
PFS is defined as the time from treatment start until the earliest date of tumor progression according RECIST 1.1 based on investigator review or death from any cause, whichever occurs first.
Time frame: up to 50 months
Dose optimization and justification (Phase II): Disease control (DC)
DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by investigator review.
Time frame: up to 50 months
Dose optimization and justification (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period
Time frame: up to 50 months
Dose optimization and justification (Phase II): Maximum measured concentration (at steady state) (Cmax,(ss))
Time frame: up to 50 months
Dose optimization and justification (Phase II): Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
Time frame: up to 50 months
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library was developed to elicit symptomatic toxicity information directly from patients in cancer clinical trials. The items selected for this trial are: Mouth/throat sores, Taste changes, Decreased appetite, Nausea, Vomiting, Constipation, Diarrhoea, Shortness of breath, Cough, Rash, Skin dryness, Hair loss, Itching, Numbness \& Tingling, Fatigue, Nosebleed, Headache. PRO-CTCAE responses are scored from 0 (=none) to 4 (=very severe) (or 0/1 for absent/present).
Time frame: up to 24 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL46
The EORTC IL46 is a single question that assesses bother (burden) of treatment. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
Time frame: up to 48 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL19
The EORTC IL19 consists of five physical functioning scale items. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
Time frame: up to 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California Los Angeles
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of California Irvine
Orange, California, United States
RECRUITINGSharp Memorial Hospital
San Diego, California, United States
NOT_YET_RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGMayo Clinic - Florida
Jacksonville, Florida, United States
NOT_YET_RECRUITINGH. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
NOT_YET_RECRUITING...and 93 more locations