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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Intravenous (IV) Infusion
Gabrail Cancer Center
Ohio City, Ohio, United States
RECRUITINGPart 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
All parts : Treatment-Emergent Adverse Events (TEAE)
Incidence of SAEs, SUSARs, TEAEs, and AESI
Time frame: Up to 24 months
All parts : Immunogenicity (ADA)
Blood samples were collected and assessed by validated immunoassays for immunogenicity of CKD-703, including the incidence of anti-drug antibodies (ADA)
Time frame: Up to 24 months
All parts : Immunogenicity (NAb)
Blood samples were collected and assessed by validated immunoassays for immunogenicity of CKD-703, including the incidence of neutralizing antibodies (NAb)
Time frame: Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter
CKD-703 (conjugated antibody)
Time frame: Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter
Total antibody
Time frame: Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter
Free MMAE
Time frame: Up to 24 months
Part 1 and Part 3 : Best Overall Response (BOR)
Defined as best objective response of CR, PR, SD, PD, or not evaluable at the end of treatment
Time frame: Up to 24 months
All parts : Duration of Response (DoR)
Defined as the time from the date of first documented CR or PR until the date of documented progression or death
Time frame: Up to 24 months
Part 2 and Part 3 : Progression-Free Survival (PFS)
Defined as the time from the date of first dose to the date of progression or death
Time frame: Up to 24 months
Part 2 and Part 3 : Overall Survival (OS)
Defined as the time from first dose to the date of death
Time frame: Up to 24 months
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