A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CKD-703.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors, Non-Small Cell Lung Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug CKD-703
Intravenous (IV) Infusion
Primary outcome measures
- Part 1: Number of patients with dose limiting toxicity (DLT) [Time frame: first 21-day period of therapy]
- Part 2 and Part 3: Object Response Rate (ORR) [Time frame: Up to 24 months]
Secondary outcome measures (10)
- 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
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Gabrail Cancer Center — Ohio City
Identifiers
NCT: NCT07439094 · A161_01ST/NSCLC2503