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Advanced Solid TumorsPhase 1/2NCT07439094

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

A Phase 1/2 study testing CKD-703 in people with Advanced Solid Tumors and Non-Small Cell Lung Cancer, run by Chong Kun Dang Pharmaceutical at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
CKD-703
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited States
Study dates
16 Apr 2026to Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Gabrail Cancer Center

    Ohio City, Ohio, 44718

    Gabrail Cancer Center, 330-492-3345, recruitment@gabrailcancercenter.com

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
CKD-703
Keywords
c-Met, CKD-703, Advanced Solid Tumors, Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-703Drug

    Intravenous (IV) Infusion

Study groups in NCT07439094
Study groupRoleWhat they receive
Part 1ExperimentalParticipants with advanced solid tumors will receive escalating dose of CKD-703
Receives: Drug: CKD-703
Part 2ExperimentalParticipants with nsqNSCLC will receive CKD-703
Receives: Drug: CKD-703
Part 3ExperimentalParticipants with advanced solid tumors will receive CKD-703
Receives: Drug: CKD-703

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of patients with dose limiting toxicity (DLT)

    Collect all adverse events at each visit

    Measured: first 21-day period of therapy

  2. 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

    Measured: Up to 24 months

Secondary outcomes (10)

  1. All parts : Treatment-Emergent Adverse Events (TEAE)

    Incidence of SAEs, SUSARs, TEAEs, and AESI

    Measured: Up to 24 months

  2. 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)

    Measured: Up to 24 months

  3. 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)

    Measured: Up to 24 months

  4. Part 1 and Part 2 : Pharmacokinetic parameter

    CKD-703 (conjugated antibody)

    Measured: Up to 24 months

  5. Part 1 and Part 2 : Pharmacokinetic parameter

    Total antibody

    Measured: Up to 24 months

  6. Part 1 and Part 2 : Pharmacokinetic parameter

    Free MMAE

    Measured: Up to 24 months

  7. 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

    Measured: Up to 24 months

  8. 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

    Measured: Up to 24 months

  9. 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

    Measured: Up to 24 months

  10. Part 2 and Part 3 : Overall Survival (OS)

    Defined as the time from first dose to the date of death

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start16 Apr 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07439094
Sponsor's protocol ID
A161_01ST/NSCLC2503
Status last verified
Apr 2026
First submitted
13 Feb 2026
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CKD-703 in people with Advanced Solid Tumors and Non-Small Cell Lung Cancer, run by Chong Kun Dang Pharmaceutical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of patients with dose limiting toxicity (DLT) (time frame: first 21-day period of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07439094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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