Actively Recruiting
A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer
Led by Chong Kun Dang Pharmaceutical · Updated on 2026-04-27
140
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 19 years or older
- Solid tumors including NSCLC for which standard therapy has failed or was not tolerated, and no other effective therapy exists (Part 1)
- Histologically or cytologically confirmed c-Met overexpressing nonsquamous NSCLC after failure of at least one line of standard care therapy (Part 2)
- Histologically or cytologically confirmed c-Met expressing solid tumors after failure or intolerance of standard therapy (Part 3)
- NSCLC patients with actionable genetic alterations must have failed at least one line of approved targeted therapies
- Life expectancy of at least 12 weeks as judged by the investigator
- Documented progressive and measurable disease by RECIST 1.1
- ECOG Performance Status of 0 or 1
You will not qualify if you...
- Radiation therapy to the lung within 6 months prior to first dose
- Prior radiotherapy to 25% or more of bone marrow
- Anticancer systemic therapy (immunotherapy, biologic, chemotherapy, investigational therapy) within 28 days prior to first dose
- Small molecule anticancer therapy or herbal therapy within 14 days prior to first dose
- Prior c-Met-targeted antibody therapy or MMAE-containing antibody-drug conjugates
- Use of strong P-gp and/or CYP3A4/5 inducers within 21 days prior or inhibitors within 14 days prior to first dose
- Use of sensitive CYP3A4/5 substrate within 3 days or five half-lives prior to first dose
- Evidence of pulmonary fibrosis or history of pneumonitis requiring systemic steroids within 12 months
- History of drug-induced interstitial lung disease
- Prior or active ocular or corneal disease based on ophthalmic exam
- Prior Grade 3 neuropathy or chronic Grade 2 neuropathy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gabrail Cancer Center
Ohio City, Ohio, United States, 44718
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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