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CKD-703 for Advanced Solid Tumors and Non-Small Cell Lung Cancer

This study is testing a new treatment called CKD-703 for people with advanced solid tumors or non-small cell lung cancer (NSCLC) where standard treatments haven't worked or weren't tolerated. CKD-703 is designed to target a specific protein called c-Met, which is found on some cancer cells. It works like a guided missile, delivering a powerful anti-cancer drug directly to these cells, aiming to be more effective and have fewer side effects. To join, you must be at least 19 years old. For NSCLC, your cancer must show high levels of c-Met. The study will look at the safety of CKD-703 and how well it shrinks tumors. The study is currently unclear on its recruitment status and plans to enroll about 140 participants.

Study design
This is a Phase 1/2a study, meaning it's an early-stage trial looking at safety and effectiveness. It is open-label, so both you and your doctors will know you are receiving CKD-703.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07439094

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

Recruiting
PHASE1Ages 19+InterventionalTreatment
Chong Kun Dang Pharmaceutical
~140 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:CKD-703

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of patients with dose limiting toxicity (DLT)
Measured over first 21-day period of therapy
+1 more outcome measured

Conditions

Advanced Solid Tumors
Non-Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Gabrail Cancer Center
[email protected]
330-492-3345
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part 1: Number of patients with dose limiting toxicity (DLT)first 21-day period of therapy

    Collect all adverse events at each visit

  • Part 2 and Part 3: Object Response Rate (ORR)Up to 24 months

    ORR defined as the proportion of subjects with a best Investigator-assessed confirmed objective response of CR or PR according to RECIST 1.1