Status and phase
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About
This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.
Full description
This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Patients with the following indications:
i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
ECOG Performance Status of 0-2
Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
Willingness and ability to comply with all study procedures
Written informed consent obtained prior to any screening procedures
During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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