CKD-703 for Non-Small Cell Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Chong Kun Dang Pharmaceutical

Must not be taking: Immunotherapy, Biologic, Cytotoxic, others

Disqualifiers: Radiation therapy, Pulmonary fibrosis, others

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

Compensation: Varies

Number of Visits: Unknown

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

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: Part 3 Experimental Treatment 1 Intervention

Participants with advanced solid tumors will receive CKD-703

Group II: Part 2 Experimental Treatment 1 Intervention

Participants with nsqNSCLC will receive CKD-703

Group III: Part 1 Experimental Treatment 1 Intervention

Participants with advanced solid tumors will receive escalating dose of CKD-703

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

Chong Kun Dang Pharmaceutical

Chief Medical Officer since 2021

MD

Choi Hee-nam

Chong Kun Dang Pharmaceutical

Chief Executive Officer since 2024

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