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
Summary
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.
Arms & interventions
- DrugCKD-703
Intravenous (IV) Infusion
Outcome measures
Primary
Part 1: Number of patients with dose limiting toxicity (DLT)
Collect all adverse events at each visit
Time frame: first 21-day period of therapy
Part 2 and Part 3: Object Response Rate (ORR)
ORR defined as the proportion of subjects with a best Investigator-assessed confirmed objective response of CR or PR according to RECIST 1.1
Time frame: Up to 24 months
Secondary
All parts : Treatment-Emergent Adverse Events (TEAE)
Time frame: Up to 24 months
All parts : Immunogenicity (ADA)
Time frame: Up to 24 months
All parts : Immunogenicity (NAb)
Time frame: Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter
Time frame: Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter
Time frame: Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter
Time frame: Up to 24 months
Part 1 and Part 3 : Best Overall Response (BOR)
Time frame: Up to 24 months
All parts : Duration of Response (DoR)
Time frame: Up to 24 months
Part 2 and Part 3 : Progression-Free Survival (PFS)
Time frame: Up to 24 months
Part 2 and Part 3 : Overall Survival (OS)
Time frame: Up to 24 months
Eligibility criteria
Study locations (1)
Gabrail Cancer Center
Ohio City, Ohio, 44718