First-in-human open-label dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors

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First-in-human open-label dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors

Brief description of study

The purpose of the study is to determine the safety of GEN1046 in patients with malignant solid tumors. GEN1046 is investigational drug in this study because it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States. The main goal of this research study is to determine the maximum tolerated dose (MTD) of an investigational drug and see if the drug is safe when given to people with malignant solid tumors.

Clinical Study Identifier: s19-01575

ClinicalTrials.gov Identifier: NCT03917381

Principal Investigator: Elaine Shum.

Other Investigators: Samantha VanMaanen, Jessica Wang, Salman Rafi Punekar, Sally Lau, Joshua K Sabari, David Mendoza, Melissa L Martinez, Vamsidhar Velcheti, Avital Benson, Natalia Cherkassky.

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Perlmutter Cancer Center

Clinical Trials & Research Studies