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Non-Small Cell Lung CancerPhase 1CKD-702NCT04667975

The Purpose of Study is to Evaluate the Safety, Pharmacokinetics and Anti-tumor Effects of CKD-702 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer Who Failed to Standard Therapy

A Phase 1 study testing CKD-702 in people with Non-Small Cell Lung Cancer, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of study is to evaluate the safety, pharmacokinetics and anti-tumor effects of CKD-702 as a monotherapy and to determine the Recommended Phase 2 Dose(RP2D) in patients with advanced or metastatic non-small cell lung cancer who failed to standard therapy. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
CKD-702
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteSouth Korea
Study dates
21 May 2020to 30 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Those aged 19 years or older
  • Patients with a definitive histological or cytological diagnosis of advanced or metastatic non-small-cell lung cancer (NSCLC) (according to the Cancer Staging Manual, AJCC/UICC, 8th ed., IIIB, IIIC and IV) and those for whom there was no applicable standard therapy or the standard therapy failed.
  • Those whose ECOG performance status is either 0 or 1
  • Patients who voluntarily decide to participate in this study and provide their written consent.

Who cannot join

  • Patients whose toxicity due to previous anticancer therapy has not been reduced to Grade 1 or lower (However, hair loss of not less than Grade 2 and the peripheral neuropathy of Grade 2 are allowed)
  • Patients with malignant tumors other than NSCLC within the past 3 years of screening (However, treated local basal cell carcinoma or squamous cell carcinoma of skin, carcinoma in situ of uterine cervix, superficial bladder cancer, papillary thyroid carcinoma or, in the opinion of the investigator, malicious tumors that are considered to have little or no recurrence risk within 1 year, are permitted)
  • Patients with a history of serious heart disease such as acute ischemic heart disease within the past 6 months of screening (myocardial infarction, unstable angina, etc.) or heart failure of NYHA Class III or IV
  • Patients who have tested positive for HIV antibodies
  • Uncontrolled hypertension, diabetes patients
  • Patients who have not fully recovered from a major surgery or severe trauma before beginning treatment, or who are expected to undergo a major surgery during the study period or within 6 months of the final dose of the study drug.

Trial locations and contacts

1 site in 1 country.

Keehyun Ham contact

82-2-6373-0916

hamki@ckdpharm.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Dong-Wan Kim, MD

    Recruiting

Other trials in South Korea

About this study

Official title: A Multicenter, Open-Label, Dose-Escalation and Dose-Expansion, Phase I Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Effects of CKD-702 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer Who Failed to Standard Therapy

The purpose of study is to evaluate the safety, pharmacokinetics and anti-tumor effects of CKD-702 as a monotherapy and to determine the Recommended Phase 2 Dose(RP2D) in patients with advanced or metastatic non-small cell lung cancer who failed to standard therapy.

Read the detailed description

This open label, multi center, first-in-human study consists of 2parts.

-Part 1: The dose is increased according to the prescribed dose escalation schedule.

Dose escalation proceeds until the maximum tolerated dose(MTD) is reached. Dose-limiting toxicity (DLT) is evaluated after completing cycle 1 administration for all subjects enrolled for each dose group in order to determine whether to proceed to the next level. all matters related to dose escalation are subject to the decision of the SRC. If DLT occurs in two subjects during the first dose level process, the dose level reset by the SRC is reflected and study protocol amendment procedure is followed accordingly. Following completion of the DLT evaluation of the planned dose level in this study, the SRC reviews the outcome of the evaluation and determines whether to set additional dosing or proceed to PART 2 (Dose expansion).

-Part 2: In Part 2, the recommended phase 2 dose (RP2D) of the CKD-702 Inj. determined in Part 1 is set as the treatment dose, and the dose must be administered with the same administration methods as Part 1, repeating cycles.

Being tested
CKD-702
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-702Drug

    In principle, based on 1 cycle of 28 days (4 weeks), administer CKD-702 Inj. once every 2 weeks over 4 weeks.

Study groups in NCT04667975
Study groupRoleWhat they receive
Part 1(Dose escalation)ExperimentalPart 1: 3 or 6 subjects are enrolled, per each dose group in a traditional 3+3 design. Begin with the starting dose determined by the non-clinical study and increase the dose according to the dose levels. If DLT does not occur in the 3 subjects when they have completed the 1st cycle at each dose level, increase the dose to the next level. Dose escalation proceeds until the maximum tolerated dose (MTD) is reached. Dose-limiting toxicity (DLT) is evaluated following the completion of dosing for the 1st cycle of all subjects enrolled in each dose group in order to determine whether to proceed to the next level. Following completion of the DLT evaluation of the planned dose level in this study, the SRC reviews the outcome of the evaluation and determines whether to set additional dosing or proceed to PART 2 (Dose expansion).
Receives: Drug: CKD-702
Part 2(Dose expansion)ExperimentalPart 2: The primary objective of Part 2 is to evaluate the efficacy of CKD-702 by identifying the ORR after administering the RP2D of CKD-702 determined in Part 1. Along with this, to determine the CKD-702 effective patient group, the patient groups were classified into several cohorts based on non-clinical study results. Therefore, in Part 2, the RP2D determined in Part 1 is administered until the occurrence of an adverse event causing PD occurrence, death or treatment discontinuation, and tumor response is evaluated based on RECIST version 1.1.
Receives: Drug: CKD-702

What is being measured

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

  1. Part 1: Maximum Tolerated Dose and/or Recommended Phase 2 Dose

    To determine the maximum tolerated dose (MTD) and/or the recommended phase 2dose (RP2D)

    Measured: Through study completion, an average of 2years

  2. Part 2: Objective Response Rate

    To evaluate the objective response rate(ORR)

    Measured: Through study completion, an average of 2years

Secondary outcomes (25)

  1. Part 1(Dose Escalation): Pharmacokinetics(AUClast of CKD-702 after a single dose)

    1. AUClast of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  2. Part 1(Dose Escalation): Pharmacokinetics( AUCinf of CKD-702 after a single dose)

    1. AUCinf of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  3. Part 1(Dose Escalation): Pharmacokinetics(Cmax of CKD-702 after a single dose)

    1. Cmax of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  4. Part 1(Dose Escalation): Pharmacokinetics(t1/2 of CKD-702 after a single dose)

    1. t1/2 of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  5. Part 1(Dose Escalation): Pharmacokinetics(Tmax of CKD-702 after a single dose)

    1. Tmax of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  6. Part 1(Dose Escalation): Pharmacokinetics(CL of CKD-702 after a single dose)

    1. CL of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  7. Part 1(Dose Escalation): Pharmacokinetics(Vz of CKD-702 after a single dose)

    1. Vz of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  8. Part 1(Dose Escalation): Pharmacokinetics(MRT of CKD-702 after a single dose)

    1. MRT of CKD-702 after a single dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  9. Part 1(Dose Escalation): Pharmacokinetics(AUClast CKD-702 after a repeated dose)

    1. AUClast CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  10. Part 1(Dose Escalation): Pharmacokinetics(Cmax,ss CKD-702 after a repeated dose)

    1. Cmax,ss CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  11. Part 1(Dose Escalation): Pharmacokinetics(Cmin,ss CKD-702 after a repeated dose)

    1. Cmin,ss CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  12. Part 1(Dose Escalation): Pharmacokinetics(Cav,τ CKD-702 after a repeated dose)

    1. Cav,τ CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  13. Part 1(Dose Escalation): Pharmacokinetics(t1/2 CKD-702 after a repeated dose)

    1. t1/2 CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  14. Part 1(Dose Escalation): Pharmacokinetics(Tmax,ss CKD-702 after a repeated dose)

    1. Tmax,ss CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  15. Part 1(Dose Escalation): Pharmacokinetics(CLss CKD-702 after a repeated dose)

    1. CLss CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  16. Part 1(Dose Escalation): Pharmacokinetics(Vss CKD-702 after a repeated dose)

    1. Vss CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  17. Part 1(Dose Escalation): Pharmacokinetics(MRT CKD-702 after a repeated dose)

    1. MRT CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  18. Part 1(Dose Escalation): Pharmacokinetics(accumulation ratio CKD-702 after a repeated dose)

    1. accumulation ratio CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  19. Part 1(Dose Escalation): Pharmacokinetics(PTF of CKD-702 CKD-702 after a repeated dose)

    1. PTF of CKD-702 CKD-702 after a repeated dose

    Measured: C1D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs, C2D1 Pre-dose, Start of Infusion 0.5, 1hr, End of Infusion and End of Infusion 2, 6, 22, 70, 166, 336hrs

  20. Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab)

    -Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab

    Measured: C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,

  21. Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)

    -Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)

    Measured: C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,

  22. Part 2(Dose Expansion): Overall Survival

    To evaluate overall survival (OS)

    Measured: Through study completion, an average of 3years

  23. Part 2(Dose Expansion): Progression-Free Survival

    To evaluate progression-free survival (PFS)

    Measured: Through study completion, an average of 3years

  24. Part 2(Dose Expansion): Duration of Response

    To evaluate the duration of response (DoR)

    Measured: Through study completion, an average of 3years

  25. Part 2(Dose Expansion): Disease Control Rate

    To evaluate the disease control rate (DCR)

    Measured: Through study completion, an average of 3years

Timeline

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

  1. First posted16 Dec 2020
  2. Study start21 May 2020
  3. Primary completion15 Aug 2021 (estimated)
  4. Study completion30 Aug 2024 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
* Part 1(Dose Escalation) 1. Level 1(10mg/kg) 2. Level 2(15mg/kg) 3. Level 3(20mg/kg) 4. Level 4(25mg/kg) * Part 2(Dose Expansion) 1. EGFR TKI resistance 2. EGFR Wild Type
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04667975
Sponsor's protocol ID
187NSCLC18021
Acronym
CKD-702
Status last verified
Dec 2020
First submitted
29 Sep 2020
Last updated
16 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-702 in people with Non-Small Cell Lung Cancer, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. 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 South Korea. 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Keehyun Ham (82-2-6373-0916, hamki@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum Tolerated Dose and/or Recommended Phase 2 Dose (time frame: Through study completion, an average of 2years). 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 NCT04667975.

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 16 Dec 2020.

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