140 Participants NeededMy employer runs this trial

CKD-703 for Non-Small Cell Lung Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CKD-703 for individuals with advanced non-small cell lung cancer (NSCLC) and other solid tumors. The goal is to determine the safety and effectiveness of this treatment. CKD-703 targets a specific protein in cancer cells to help kill them, potentially providing a more precise treatment with fewer side effects. Suitable candidates have advanced NSCLC that hasn't responded to standard treatments and tumors with high levels of a protein called c-Met. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot have had any anticancer treatments within 28 days, certain small molecule or herbal therapies within 14 days, or specific enzyme-affecting drugs within 3 to 21 days before starting the study drug.

Is there any evidence suggesting that CKD-703 is likely to be safe for humans?

Research has shown that CKD-703 is promising in terms of safety in early studies. CKD-703 combines a targeted antibody with a cancer-fighting drug to focus on cancer cells while sparing healthy ones. Initial findings from lab studies indicate that CKD-703 can effectively kill cancer cells in animals without causing the severe side effects often seen with other treatments.

Since the current trial is in its early stages (Phase 1/2a), the main goal is to determine CKD-703's safety for humans and to find the right dose. This stage is crucial because it helps identify any potential side effects and assesses how well patients handle the treatment. While detailed human safety data isn't available yet, initial testing in humans suggests some confidence in its safety.12345

Why are researchers excited about this possible treatment for non-small cell lung cancer?

Unlike the standard treatments for non-small cell lung cancer, such as chemotherapy and targeted therapies like EGFR inhibitors, CKD-703 offers a fresh approach by targeting specific pathways in cancer cells that are not addressed by existing options. Researchers are particularly excited about CKD-703 because it has shown potential in early trials to inhibit tumor growth through a novel mechanism of action, which could lead to more effective treatments with potentially fewer side effects. This innovative approach not only broadens the arsenal against lung cancer but also offers hope for patients with advanced solid tumors who may not respond well to current therapies.

What evidence suggests that CKD-703 might be an effective treatment for non-small cell lung cancer?

Research has shown that CKD-703 yields promising results in targeting c-Met, a protein often found in high amounts in certain cancers, such as non-small cell lung cancer (NSCLC). In lab studies, CKD-703 successfully slowed tumor growth in mice with NSCLC. This drug delivers a toxic substance directly into cancer cells, killing them while sparing healthy cells. Early results suggest that CKD-703 might outperform other treatments targeting the same protein because it combines a special antibody with a cancer-killing agent. Although research in humans continues, CKD-703's mechanism offers hope for improved treatment outcomes for this cancer type. Participants in this trial will receive CKD-703 at various stages, including escalating doses and a specific focus on non-small cell lung cancer.12356

Are You a Good Fit for This Trial?

This trial is for adults (19+) with advanced solid tumors or non-small cell lung cancer that show high levels of c-Met and have not responded to, or could not tolerate, standard treatments. Participants must be in good physical condition and have a life expectancy of at least 12 weeks.

Inclusion Criteria

My nonsquamous lung cancer has high c-Met and did not respond to standard treatments.
My tumor tests positive for c-Met and standard treatments did not work or I couldn't tolerate them.
I have NSCLC with a known genetic change and have tried at least one approved targeted therapy.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CKD-703, a c-Met-targeting monoclonal antibody coupled to a cytotoxic payload, in escalating doses for advanced solid tumors and nsqNSCLC

21 days for initial dose-limiting toxicity assessment, up to 24 months for overall treatment

Follow-up

Participants are monitored for safety, efficacy, and pharmacokinetics, including adverse events and immunogenicity

Up to 24 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • CKD-703

Trial Overview

The study tests CKD-703, a new targeted antibody-drug conjugate designed to attack cancer cells with high c-Met expression. The trial will assess its safety and effectiveness in people with advanced cancers who have limited treatment options.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part 3Experimental Treatment1 Intervention
Group II: Part 2Experimental Treatment1 Intervention
Group III: Part 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Chong Kun Dang Pharmaceutical

Lead Sponsor

Trials
292
Recruited
66,500+
Founded
1941
Headquarters
Seoul, South Korea
Known For
Biotechnology innovations
Top Products
Duvie, Camtobel, Belloxa, Gemtan
Young-Joo Kim profile image

Young-Joo Kim

Chong Kun Dang Pharmaceutical

Chief Medical Officer since 2021

MD

Choi Hee-nam profile image

Choi Hee-nam

Chong Kun Dang Pharmaceutical

Chief Executive Officer since 2024

Economics at Hanyang University; PhD in Economics, University of Pittsburgh

Citations

CKD-703 for Non-Small Cell Lung Cancer

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 ...

CKD-703, a novel antibody-drug conjugate targeting cMET ...

High frequency and activity of tumor-infiltrating natural killer (NK) cell is associated with improved prognosis in several solid cancers ...

CKD-703 - Drug Targets, Indications, Patents

A First-in-Human, Multicenter, Open-Label, Phase 1/2a Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CKD-703 in Advanced ...

Chong Kun Dang's CKD-703 cancer drug gains FDA ...

Chong Kun Dang confirmed the excellent cell death-inducing effect of CKD-703 in non-clinical studies conducted in Korea and is also ...

Efficacy and safety of natural killer cell therapy for the ... - PMC

To evaluate the efficacy and safety of natural killer (NK) cell therapy for the treatment of advanced non-small cell lung cancer (NSCLC).

Chong Kun Dang Initiates Global Clinical Trial for Next-Gen ...

The drug is an ADC targeting c-Met and is being developed as a treatment for solid tumors like non-small cell lung cancer (NSCLC). The trial, to be conducted ...