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

Non-Small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667975
• Other study ID #: 187NSCLC18021
• Status: Recruiting
• Phase: Phase 1
• Start date: May 21, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: December 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: Keehyun Ham
• Phone: 82-2-6373-0916
• Email: hamki[@]ckdpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: August 30, 2024
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• CKD-702
In principle, based on 1 cycle of 28 days (4 weeks), administer CKD-702 Inj. once every 2 weeks over 4 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Asan Medical Center, Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Through study completion, an average of 2years
Primary	Part 2: Objective Response Rate	To evaluate the objective response rate(ORR)	Through study completion, an average of 2years
Secondary	Part 1(Dose Escalation): Pharmacokinetics(AUClast of CKD-702 after a single dose)	1) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics( AUCinf of CKD-702 after a single dose)	2) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Cmax of CKD-702 after a single dose)	3) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(t1/2 of CKD-702 after a single dose)	4) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Tmax of CKD-702 after a single dose)	5) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(CL of CKD-702 after a single dose)	6) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Vz of CKD-702 after a single dose)	7) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(MRT of CKD-702 after a single dose)	8) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(AUClast CKD-702 after a repeated dose)	9) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Cmax,ss CKD-702 after a repeated dose)	10) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Cmin,ss CKD-702 after a repeated dose)	11) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Cav,t CKD-702 after a repeated dose)	12) Cav,t 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(t1/2 CKD-702 after a repeated dose)	13) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Tmax,ss CKD-702 after a repeated dose)	14) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(CLss CKD-702 after a repeated dose)	15) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(Vss CKD-702 after a repeated dose)	16) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(MRT CKD-702 after a repeated dose)	17) 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
Secondary	Part 1(Dose Escalation): Pharmacokinetics(accumulation ratio CKD-702 after a repeated dose)	18) 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
Secondary	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	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
Secondary	Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab)	-Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab	C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,
Secondary	Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)	-Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)	C1D1 Pre-dose, C1D15 Pre-dose, C2D1 Pre-dose, C3D1 Pre-dose, C4D1 Pre-dose,
Secondary	Part 2(Dose Expansion): Overall Survival	To evaluate overall survival (OS)	Through study completion, an average of 3years
Secondary	Part 2(Dose Expansion): Progression-Free Survival	To evaluate progression-free survival (PFS)	Through study completion, an average of 3years
Secondary	Part 2(Dose Expansion): Duration of Response	To evaluate the duration of response (DoR)	Through study completion, an average of 3years
Secondary	Part 2(Dose Expansion): Disease Control Rate	To evaluate the disease control rate (DCR)	Through study completion, an average of 3years