Status:
UNKNOWN
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
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Collaborating Sponsors:
Seoul National University Hospital
Asan Medical Center
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 met...
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 maximu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04667975
Start Date
May 21 2020
End Date
August 30 2024
Last Update
December 16 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea