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Site for CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors (ELVCAP-001-01)(20-095)
Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
Most of the examinations, tests and procedures are part of the usual approach for your cancer. However, there will be extra procedures like blood draws and additional tests on your tumor to determine if your condition is suitable to take part in this study. There are three stages to this study: Screening, Study Treatment period, End of Study Treatment/Follow-up.
Irina Geier - at igeier@pennstatehealth.psu.edu
All
18 year(s) or older
NCT04383210
SITE00000889
Inclusion Criteria:
Locally-advanced or metastatic solid tumor with an NRG1 gene fusionAvailability of fresh or archived tumor sample
Minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies
ECOG performance status 0, 1 or 2
At least one measurable extra-cranial lesion
Exclusion Criteria:
Non - NRG-1 mutationsLife expectancy < 3 months
Pregnant or lactating
Symptomatic or untreated brain metastases
Known hypersensitivity to any of the components of seribantumab
Cancer