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Anti-tumor agent

Part 1(Dose escalation) for Non-Small Cell Lung Cancer (CKD-702 Trial)

Phase 1

Waitlist Available

Led By Dong-Wan Kim, MD

Research Sponsored by Chong Kun Dang Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 3years

Awards & highlights

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.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 3years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 3years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Maximum Tolerated Dose and/or Recommended Phase 2 Dose

Part 2: Objective Response Rate

Secondary study objectives

Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for Vectibix scFv (anti-EGFR)

Part 1(Dose Escalation): Immunogenicity(Analyze the idiotype antibody for hu8C4 (anti-cMET) Fab)

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

+22 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2(Dose expansion)Experimental Treatment1 Intervention

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.

Group II: Part 1(Dose escalation)Experimental Treatment1 Intervention

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).

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Find a Location

Who is running the clinical trial?

Samsung Medical CenterOTHER

1,039 Previous Clinical Trials

10,771,171 Total Patients Enrolled

Chong Kun Dang PharmaceuticalLead Sponsor

283 Previous Clinical Trials

55,927 Total Patients Enrolled

Seoul National University HospitalOTHER

1,886 Previous Clinical Trials

6,301,477 Total Patients Enrolled

~14 spots leftby Sep 2025

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