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

NCT07439094 | Recruiting Phase 1 FDA Drug

• 1 other identifier: A161_01ST/NSCLC2503
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors; Non-Small Cell Lung Cancer

Keywords

c-Met; CKD-703; Advanced Solid Tumors; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• All parts : Treatment-Emergent Adverse Events (TEAE)

  Up to 24 months

• All parts : Immunogenicity (ADA)

  Up to 24 months

• All parts : Immunogenicity (NAb)

  Up to 24 months

• Part 1 and Part 2 : Pharmacokinetic parameter

  Up to 24 months

• Part 1 and Part 2 : Pharmacokinetic parameter

  Up to 24 months

Study Arms (3)

Part 1

EXPERIMENTAL

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

Drug: CKD-703

Part 2

EXPERIMENTAL

Participants with nsqNSCLC will receive CKD-703

Drug: CKD-703

Part 3

EXPERIMENTAL

Participants with advanced solid tumors will receive CKD-703

Drug: CKD-703

Interventions

CKD-703 DRUG

Intravenous (IV) Infusion

Part 1; Part 2; Part 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Gabrail Cancer Center

Ohio City, Ohio, 44718, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 27, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)