A First-in-Human Study of CKD-703 in 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 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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer; Advanced Solid Tumors
• Intervention / Treatment: Drug: CKD-703

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Ohio City, Ohio, United States, 44718
      • Recruiting
      • Gabrail Cancer Center
      • Contact: Gabrail Cancer Center; Phone Number: 330-492-3345; Email: recruitment@gabrailcancercenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Participants with advanced solid tumors will receive escalating dose of CKD-703	Drug: CKD-703; Intravenous (IV) Infusion
Experimental: Part 2; Participants with nsqNSCLC will receive CKD-703	Drug: CKD-703; Intravenous (IV) Infusion
Experimental: Part 3; Participants with advanced solid tumors will receive CKD-703	Drug: CKD-703; Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of patients with dose limiting toxicity (DLT)	Collect all adverse events at each visit	first 21-day period of therapy
Part 2 and Part 3: Object Response Rate (ORR)	ORR defined as the proportion of subjects with a best Investigator-assessed confirmed objective response of CR or PR according to RECIST 1.1	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All parts : Treatment-Emergent Adverse Events (TEAE)	Incidence of SAEs, SUSARs, TEAEs, and AESI	Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter	CKD-703 (conjugated antibody)	Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter	Total antibody	Up to 24 months
Part 1 and Part 2 : Pharmacokinetic parameter	Free MMAE	Up to 24 months
Part 1 and Part 3 : Best Overall Response (BOR)	Defined as best objective response of CR, PR, SD, PD, or not evaluable at the end of treatment	Up to 24 months
All parts : Duration of Response (DoR)	Defined as the time from the date of first documented CR or PR until the date of documented progression or death	Up to 24 months
Part 2 and Part 3 : Progression-Free Survival (PFS)	Defined as the time from the date of first dose to the date of progression or death	Up to 24 months
Part 2 and Part 3 : Overall Survival (OS)	Defined as the time from first dose to the date of death	Up to 24 months
All parts : Immunogenicity (ADA)	Blood samples were collected and assessed by validated immunoassays for immunogenicity of CKD-703, including the incidence of anti-drug antibodies (ADA)	Up to 24 months
All parts : Immunogenicity (NAb)	Blood samples were collected and assessed by validated immunoassays for immunogenicity of CKD-703, including the incidence of neutralizing antibodies (NAb)	Up to 24 months

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; Advanced Solid Tumors; c-Met; CKD-703
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: A161_01ST/NSCLC2503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No