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

Part of paid clinical trials in Ohio City, Ohio.

Sponsor
Chong Kun Dang Pharmaceutical
Study ID
NCT07439094
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CKD-703 — DRUG
    Intravenous (IV) Infusion

Study Details

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.

Key Dates

Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Participants with advanced solid tumors will receive escalating dose of CKD-703
  • Experimental: Part 2
    Participants with nsqNSCLC will receive CKD-703
  • Experimental: Part 3
    Participants with advanced solid tumors will receive CKD-703

Primary Outcome Measure

Part 1: Number of patients with dose limiting toxicity (DLT) [ Time Frame: first 21-day period of therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Gabrail Cancer CenterOhio CityOhio44718
Gabrail Cancer Center
330-492-3345

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