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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

Phase 1
Conditions
Non-Small Cell Lung Cancer
Interventions
Drug: CKD-702
Registration Number
NCT04667975
Lead Sponsor
Chong Kun Dang Pharmaceutical
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
74
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Part 2(Dose expansion)CKD-702Part 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.
Part 1(Dose escalation)CKD-702Part 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).
Primary Outcome Measures
NameTimeMethod
Part 1: Maximum Tolerated Dose and/or Recommended Phase 2 DoseThrough study completion, an average of 2years

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

Part 2: Objective Response RateThrough study completion, an average of 2years

To evaluate the objective response rate(ORR)

Secondary Outcome Measures
NameTimeMethod
Part 1(Dose Escalation): Pharmacokinetics( AUCinf of CKD-702 after a single dose)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) AUCinf of CKD-702 after a single dose

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

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

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

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

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

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

1) AUClast of CKD-702 after a single dose

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

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

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

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

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

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

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

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

Part 2(Dose Expansion): Progression-Free SurvivalThrough study completion, an average of 3years

To evaluate progression-free survival (PFS)

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

Part 2(Dose Expansion): Overall SurvivalThrough study completion, an average of 3years

To evaluate overall survival (OS)

Part 2(Dose Expansion): Duration of ResponseThrough study completion, an average of 3years

To evaluate the duration of response (DoR)

Part 2(Dose Expansion): Disease Control RateThrough study completion, an average of 3years

To evaluate the disease control rate (DCR)

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

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

Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,

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

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

Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab)C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,

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

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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