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

NCT04667975 | Unknown Phase 1

• 1 other identifier: 187NSCLC18021
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Part 2: Objective Response Rate

  To evaluate the objective response rate(ORR)

  Through study completion, an average of 2years

Secondary Outcomes (25)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Part 1(Dose escalation)

EXPERIMENTAL

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).

Drug: CKD-702

Part 2(Dose expansion)

EXPERIMENTAL

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.

Drug: CKD-702

Interventions

CKD-702 DRUG

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

Part 1(Dose escalation); Part 2(Dose expansion)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those aged 19 years or older
• 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.
• Those whose ECOG performance status is either 0 or 1
• Patients who voluntarily decide to participate in this study and provide their written consent.

You may not qualify if:

• 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)
• 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)
• 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
• Patients who have tested positive for HIV antibodies
• Uncontrolled hypertension, diabetes patients
• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Samsung Medical Center: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dong-Wan Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keehyun Ham

CONTACT

82-2-6373-0916; hamki@ckdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Part 1(Dose Escalation) 1. Level 1(10mg/kg) 2. Level 2(15mg/kg) 3. Level 3(20mg/kg) 4. Level 4(25mg/kg) * Part 2(Dose Expansion) 1. EGFR TKI resistance 2. EGFR Wild Type

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: December 16, 2020
• Study Start: May 21, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 30, 2024
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

KR (1)