Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2025-12-17 @ 12:53 AM
Study NCT ID:
NCT04667975
Status:
None
Last Update Posted:
2020-12-16 00:00:00
First Post:
2020-09-29 00:00:00
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
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Chong Kun Dang Pharmaceutical
Study Overview
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
Status:
None
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CKD-702
Brief Summary:
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.
-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.
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 doseMTD 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
-Part 1 The dose is increased according to the prescribed dose escalation schedule
Dose escalation proceeds until the maximum tolerated doseMTD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None