Recruiting
Phase 1
Phase 2

CKD-703

Sponsor:

Chong Kun Dang Pharmaceutical

Code:

NCT07439094

Conditions

Advanced Solid Tumors

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

CKD-703

Study Details

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

Study ID

NCT07439094

Start date

Apr 16, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1

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

experimental: Part 2

Participants with nsqNSCLC will receive CKD-703

experimental: Part 3

Participants with advanced solid tumors will receive CKD-703

Interventions

CKD-703

Intravenous (IV) Infusion

Primary outcome measure

  • Part 1: Number of patients with dose limiting toxicity (DLT) [ Time Frame: first 21-day period of therapy ]
  • Part 2 and Part 3: Object Response Rate (ORR) [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Locations

Gabrail Cancer Center

Recruiting

Ohio City, Ohio, United States, 44718

Contacts

Gabrail Cancer Center

330-492-3345recruitment@gabrailcancercenter.com

More Information

Sponsor

Chong Kun Dang Pharmaceutical

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chong Kun Dang Pharmaceutical on 2026-04-27.