Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chong Kun Dang Pharmaceutical
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Subject has received radiation therapy to the lung \< 6 months prior to the first dose of study drug
Prior radiotherapy to ≥ 25% of bone marrow
Anticancer systemic therapy such as immunotherapy, biologic, cytotoxic chemotherapy, or any investigational therapy (including cell therapy or gene therapy) within a period of 28 days prior to the first dose of study drug. Any anticancer therapy small molecule (eg. kinase inhibitor) or herbal therapy within 14 days prior to the first dose of study drug
Prior c-Met-targeted antibody therapy or any MMAE-containing ADC (prior c-Met targeting small molecules are allowed)
Use of strong P-gp and/or CYP3A4/5 inducers within 21 days prior or strong P-gp and/or CYP3A4/5 inhibitors within 14 days prior to the first dose of study drug
Use of sensitive CYP3A4/5 substrate within 3 days or 5 times half-life prior to the first dose of study drug.
Evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis that required treatment with systemic steroids within 12 months of the planned first dose of the study drug
History of drug induced interstitial lung disease
Prior or active ocular or corneal disease based on ophthalmic evaluation (slit lamp and visual acuity)
Prior Grade 3 neuropathy or chronic Grade 2 neuropathy
Clareo Health | A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer
