First-in-Human Study of CKD-703 for Advanced Solid Tumors and Non-Small Cell Lung Cancer

Inclusion Criteria

• Men and women aged 19 and older.
• For Part 1: Have advanced solid tumors, including NSCLC, where standard treatments have failed or were not tolerated, and no other effective treatments are available.
• For Part 2: Have non-squamous NSCLC with high levels of c-Met protein, having failed at least one standard treatment like platinum-based chemotherapy or immune therapy.
• For Part 3: Have solid tumors with c-Met protein where standard treatments have failed or were not tolerated.
• For all parts: If you have NSCLC with specific genetic changes, you must have tried at least one approved targeted therapy.
• Have a life expectancy of at least 12 weeks.
• Have cancer that is progressing and can be measured by scans.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

• Have had radiation therapy to the lungs within 6 months before starting the study.
• Have had radiation to 25% or more of your bone marrow.
• Have had any cancer treatment like chemotherapy or immunotherapy within 28 days before starting the study.
• Have taken small molecule cancer drugs or herbal treatments within 14 days before starting the study.
• Have previously received c-Met-targeted antibody therapy or any treatment containing MMAE.
• Are using certain medications that affect how the body processes drugs within specific time frames before starting the study.
• Have lung scarring or a history of lung inflammation requiring steroid treatment within the last year.
• Have a history of drug-induced lung disease.
• Have eye or corneal diseases based on an eye exam.
• Have severe nerve damage or chronic moderate nerve damage.