A Phase 1/2 Open-Label Multi-Center Trial to Assess Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

Brief description of study

Phase 1: Plasma exposures of orally administered CLN-081 monotherapy associated with pre-clinical efficacy can be achieved in patients with less than 18% of patients experiencing a dose limiting toxicity. Phase 2: Oral administration of CLN-081 monotherapy at one or more doses will be associated with an overall response rate of 40%.


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


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