First-in-human test of CKD-703 for advanced solid tumors and non-small cell lung cancer
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
This trial will test CKD-703, a targeted antibody–drug conjugate, in adults with advanced c‑Met–expressing solid tumors and in MET‑amplified or c‑Met–overexpressing non‑small cell lung cancer who have exhausted standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Ohio City, Ohio) |
| Trial ID | NCT07439094 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2a open-label, multicenter trial gives CKD‑703 to adults with advanced c‑Met–expressing solid tumors and to patients with MET‑amplified or c‑Met–overexpressing nonsquamous NSCLC after prior therapy. The study includes dose-escalation and expansion cohorts (Parts 1–3) to identify a safe dose, characterize pharmacokinetics, and observe anti-tumor activity measured by RECIST 1.1. CKD‑703 is an antibody–drug conjugate that links a c‑Met–targeting monoclonal antibody to the cytotoxic agent MMAE to deliver chemotherapy directly to c‑Met–positive cancer cells. Eligible patients must have measurable progressive disease, ECOG 0–1, and generally have failed standard approved therapies for their condition.
Who should consider this trial
Good fit: Ideal candidates are adults (≥19 years) with advanced, measurable c‑Met–expressing solid tumors or MET‑amplified/c‑Met–overexpressing nonsquamous NSCLC who have progressed on or cannot tolerate standard therapies and have ECOG performance status 0–1.
Not a fit: Patients without c‑Met expression or amplification, those who still have effective standard treatment options, or patients who recently received lung radiation may not be expected to benefit from this trial.
Why it matters
Potential benefit: If successful, CKD‑703 could offer a more effective, targeted treatment option for patients with c‑Met–driven tumors and potentially improve response rates while reducing some off‑target toxicity.
How similar studies have performed: Similar c‑Met–targeting antibody–drug conjugates (for example, telisotuzumab vedotin/ABBV‑399) have shown encouraging activity in MET‑high NSCLC, so the ADC approach has precedent, although CKD‑703 is being tested in humans for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ohio City, Ohio
- Gabrail Cancer Center — Ohio City, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.