A Phase 1/2a Open-Label Multi-Center Trial to Assess Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Brief description of study

The purpose of the study is to look at safety and tolerability of orally administered CLN-081 monotherapy, as single dose and after multiple doses over the course of the study. CLN-081 is a novel, potent and highly selective epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). The study drug CLN-081 is investigational, which means that 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, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s19-01652
ClinicalTrials.gov Identifier: NCT04036682
Principal Investigator: Vamsidhar Velcheti.
Other Investigators: Danny Perlaza, Carol M Lee, Elka R Travis, Salman Rafi Punekar, Elaine Shum, Jessica Wang, James Newman, Gabrielle Fridman, Joshua K Sabari, Marissa Rybstein, David Mendoza, Melissa L Martinez, Sally Lau, Jeffrey G Schneider, Avital Benson, Natalia Cherkassky, Jonathan B Kahn.


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