A First-in-Human, Multicenter, Open-Label, Phase 1/2a Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CKD-703 in Advanced c-Met Expressing Solid Tumors, and in MET Amplified and c-Met Overexpressing Non-Small Cell Lung Cancer
This is a Phase 1/2a open-label multicenter study to evaluate the safety, efficacy, and pharmacokinetics of CKD-703 in Advanced c-Met Expressing Solid Tumors, and in MET-Amplified and c-Met Overexpressing Non-Small Cell Lung Cancer. CKD-703 is composed of a c-Met-targeting monoclonal antibody (mAb) coupled to a cytotoxic payload consisting of the anti-microtubule drug monomethyl auristatin E (MMAE); thus, CKD-703 is a novel ADC offering a highly targeted approach with potential improvement of efficacy while reducing off-target effects for patients with NSCLC and other cancers.
• Males and females ≥ 19-year-old
• Part 1 : Solid tumors including NSCLC for which standard therapy has failed or was not tolerated, and no other effective therapy exists
• Part 2 : Histologically or cytologically documented c-Met overexpressing nonsquamous NSCLC having failed at least 1 line of SoC therapy (platinum-based chemotherapy and/or immune checkpoint inhibitor).
• Part 3 : Histologically or cytologically documented c-Met expressing solid tumors for which standard therapy has failed or was not tolerated.
• In all parts of the study, subjects with NSCLC with documented actionable genetic alterations must have failed at least 1 line of country-level approved targeted therapies
• Life expectancy ≥ 12 weeks as judged by the Investigator
• Documented progressive and measurable disease as defined by RECIST 1.1
• ECOG Performance Status 0 or 1