Clinical trial · Interventional
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 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
NCT04667975CI-TRIAL-00048866CKD-702unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CKD-702 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1(Dose escalation)
- 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).
- interventionNames
- Drug: CKD-702
- type
- EXPERIMENTAL
- label
- Part 2(Dose expansion)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.