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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 (CKD-702)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-702
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Those aged 19 years or older
  2. 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.
  3. Those whose ECOG performance status is either 0 or 1
  4. Patients who voluntarily decide to participate in this study and provide their written consent.

Exclusion Criteria

  1. 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)
  2. 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)
  3. 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
  4. Patients who have tested positive for HIV antibodies
  5. Uncontrolled hypertension, diabetes patients
  6. 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.

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1(Dose escalation)

Part 2(Dose expansion)

Arm Description

Part 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).

Part 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.

Outcomes

Primary Outcome Measures

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)
Part 2: Objective Response Rate
To evaluate the objective response rate(ORR)

Secondary Outcome Measures

Part 1(Dose Escalation): Pharmacokinetics(AUClast of CKD-702 after a single dose)
1) AUClast of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics( AUCinf of CKD-702 after a single dose)
2) AUCinf of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics(Cmax of CKD-702 after a single dose)
3) Cmax of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics(t1/2 of CKD-702 after a single dose)
4) t1/2 of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics(Tmax of CKD-702 after a single dose)
5) Tmax of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics(CL of CKD-702 after a single dose)
6) CL of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics(Vz of CKD-702 after a single dose)
7) Vz of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics(MRT of CKD-702 after a single dose)
8) MRT of CKD-702 after a single dose
Part 1(Dose Escalation): Pharmacokinetics(AUClast CKD-702 after a repeated dose)
9) AUClast CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(Cmax,ss CKD-702 after a repeated dose)
10) Cmax,ss CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(Cmin,ss CKD-702 after a repeated dose)
11) Cmin,ss CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(Cav,τ CKD-702 after a repeated dose)
12) Cav,τ CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(t1/2 CKD-702 after a repeated dose)
13) t1/2 CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(Tmax,ss CKD-702 after a repeated dose)
14) Tmax,ss CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(CLss CKD-702 after a repeated dose)
15) CLss CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(Vss CKD-702 after a repeated dose)
16) Vss CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(MRT CKD-702 after a repeated dose)
17) MRT CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(accumulation ratio CKD-702 after a repeated dose)
18) accumulation ratio CKD-702 after a repeated dose
Part 1(Dose Escalation): Pharmacokinetics(PTF of CKD-702 CKD-702 after a repeated dose)
19) PTF of CKD-702 CKD-702 after a repeated dose
Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab)
-Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab
Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)
-Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)
Part 2(Dose Expansion): Overall Survival
To evaluate overall survival (OS)
Part 2(Dose Expansion): Progression-Free Survival
To evaluate progression-free survival (PFS)
Part 2(Dose Expansion): Duration of Response
To evaluate the duration of response (DoR)
Part 2(Dose Expansion): Disease Control Rate
To evaluate the disease control rate (DCR)

Full Information

First Posted
September 29, 2020
Last Updated
December 11, 2020
Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Seoul National University Hospital, Asan Medical Center, Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04667975
Brief Title
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
Acronym
CKD-702
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Seoul National University Hospital, Asan Medical Center, Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Part 1(Dose Escalation) Level 1(10mg/kg) Level 2(15mg/kg) Level 3(20mg/kg) Level 4(25mg/kg) Part 2(Dose Expansion) EGFR TKI resistance EGFR Wild Type
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1(Dose escalation)
Arm Type
Experimental
Arm Description
Part 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).
Arm Title
Part 2(Dose expansion)
Arm Type
Experimental
Arm Description
Part 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.
Intervention Type
Drug
Intervention Name(s)
CKD-702
Intervention Description
In principle, based on 1 cycle of 28 days (4 weeks), administer CKD-702 Inj. once every 2 weeks over 4 weeks.
Primary Outcome Measure Information:
Title
Part 1: Maximum Tolerated Dose and/or Recommended Phase 2 Dose
Description
To determine the maximum tolerated dose (MTD) and/or the recommended phase 2dose (RP2D)
Time Frame
Through study completion, an average of 2years
Title
Part 2: Objective Response Rate
Description
To evaluate the objective response rate(ORR)
Time Frame
Through study completion, an average of 2years
Secondary Outcome Measure Information:
Title
Part 1(Dose Escalation): Pharmacokinetics(AUClast of CKD-702 after a single dose)
Description
1) AUClast of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics( AUCinf of CKD-702 after a single dose)
Description
2) AUCinf of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Cmax of CKD-702 after a single dose)
Description
3) Cmax of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(t1/2 of CKD-702 after a single dose)
Description
4) t1/2 of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Tmax of CKD-702 after a single dose)
Description
5) Tmax of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(CL of CKD-702 after a single dose)
Description
6) CL of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Vz of CKD-702 after a single dose)
Description
7) Vz of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(MRT of CKD-702 after a single dose)
Description
8) MRT of CKD-702 after a single dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(AUClast CKD-702 after a repeated dose)
Description
9) AUClast CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Cmax,ss CKD-702 after a repeated dose)
Description
10) Cmax,ss CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Cmin,ss CKD-702 after a repeated dose)
Description
11) Cmin,ss CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Cav,τ CKD-702 after a repeated dose)
Description
12) Cav,τ CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(t1/2 CKD-702 after a repeated dose)
Description
13) t1/2 CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Tmax,ss CKD-702 after a repeated dose)
Description
14) Tmax,ss CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(CLss CKD-702 after a repeated dose)
Description
15) CLss CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(Vss CKD-702 after a repeated dose)
Description
16) Vss CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(MRT CKD-702 after a repeated dose)
Description
17) MRT CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(accumulation ratio CKD-702 after a repeated dose)
Description
18) accumulation ratio CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Pharmacokinetics(PTF of CKD-702 CKD-702 after a repeated dose)
Description
19) PTF of CKD-702 CKD-702 after a repeated dose
Time Frame
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
Title
Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab)
Description
-Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab
Time Frame
C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,
Title
Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)
Description
-Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)
Time Frame
C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,
Title
Part 2(Dose Expansion): Overall Survival
Description
To evaluate overall survival (OS)
Time Frame
Through study completion, an average of 3years
Title
Part 2(Dose Expansion): Progression-Free Survival
Description
To evaluate progression-free survival (PFS)
Time Frame
Through study completion, an average of 3years
Title
Part 2(Dose Expansion): Duration of Response
Description
To evaluate the duration of response (DoR)
Time Frame
Through study completion, an average of 3years
Title
Part 2(Dose Expansion): Disease Control Rate
Description
To evaluate the disease control rate (DCR)
Time Frame
Through study completion, an average of 3years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keehyun Ham
Phone
82-2-6373-0916
Email
hamki@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Wan Kim, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Wan Kim, MD

12. IPD Sharing Statement

Learn more about this trial

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

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