Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713

NCT06012708 | Completed Phase 1 DMC

• 1 other identifier: NCCKN-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of the combination therapy of KN510 and KN713 and determine the MTD and RP2D in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumors

Outcome Measures

Primary Outcomes (5)

• DLT(dose limiting toxicity)

  DLTs will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0, and defined as CTCAE Grade ≥3 ADR(Adverse Drug Reaction)s.

  Until 28 days from the first IP administration

• AEs(Adverse Events)

  Any clinically significant medical condition or abnormality observed after IP administration will be collected as an AE.

  Through study completion, an average of 5 months

• Laboratory tests

  For collected laboratory test results, changes between before and after IP administration and/or changes in normality/abnormality will be assessed.

  Through study completion, an average of 5 months

• Vital signs

  For collected vital signs results, changes between before and after IP administration and/or changes in normality/abnormality will be assessed.

  Through study completion, an average of 5 months

• ECG(Electrocardiogram)

  ECG results will be assessed and recorded as normal or abnormal, and any clinically significant changes will be recorded as AEs in the CRF.

  Through study completion, an average of 5 months

Other Outcomes (23)

• AUClast

  Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose

• AUCinf

  Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose

• Cmax

  Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose

Study Arms (4)

Dose Level 1

EXPERIMENTAL

Drug: KN510 60mg/day + KN713 60mg/day

Dose Level 2

EXPERIMENTAL

Drug: KN510 120mg/day + KN713 60mg/day

Dose Level 3

EXPERIMENTAL

Drug: KN510 120mg/day + KN713 90mg/day

Dose Level 4

EXPERIMENTAL

Drug: KN510 120mg/day + KN713 120mg/day

Interventions

KN510 60mg/day + KN713 60mg/day DRUG

Once daily with 28 days (4 weeks) as one cycle.

Dose Level 1

KN510 120mg/day + KN713 60mg/day DRUG

Once daily with 28 days (4 weeks) as one cycle.

Dose Level 2

KN510 120mg/day + KN713 90mg/day DRUG

Once daily with 28 days (4 weeks) as one cycle.

Dose Level 3

KN510 120mg/day + KN713 120mg/day DRUG

Once daily with 28 days (4 weeks) as one cycle.

Dose Level 4

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults aged 19-75 years
• Unresectable advanced or metastatic solid tumors that are confirmed as progressive disease (PD) after the standard of care currently known to have clinical benefits, or for which no currently available standard therapies exist due to intolerance, ineligibility, rejection, etc.
• At least one measurable lesion per RECIST ver1.1
• The Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
• Life expectancy of at least 12 weeks
• Confirmed adequate hematologic, renal, and hepatic functions according to the following criteria (Laboratory tests may be repeated once during the screening period):
• A. Hematological function
• Absolute neutrophil count (ANC) ≥1,500/μL
• Hemoglobin ≥9 g/dL
• Platelet count ≥100,000/μL
• B. Renal function: Creatinine clearance (CrCl\*) \>60 mL/min
• \*Cockcroft-Gault equation
• C. Hepatic function
• Aspartate aminotransferase (AST) ≤3.0 × ULN
• Alanine aminotransferase (ALT) ≤3.0 × ULN (AST/ALT ≤5 × ULN, if hepatic metastasis is confirmed)

You may not qualify if:

• Hypersensitivity to the active ingredient or excipients of KN510 or KN713
• Any of the following medical (surgical) history or comorbidities at the screening visit:
• A. Major surgery that requires general anesthesia or a respiratory assist device within 4 weeks prior to screening (within 2 weeks for video-assisted thoracoscopic surgery \[VATS\] or open-and-closed \[ONC\] surgery)
• B. Clinically significant arrhythmia, acute myocardial infarction, unstable angina, or NYHA Grade Ⅲ or Ⅳ heart failure within 24 weeks prior to screening
• C. Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive pulmonary disease or other life-threatening severe lung disorder (e.g., acute respiratory distress syndrome, lung failure) considered ineligible for participation in the study within 24 weeks prior to screening
• D. Grade 3 or higher active infectious conditions which require systemic antibiotics, antivirals, etc. within 2 weeks prior to screening
• E. Clinically significantly symptomatic or uncontrolled central nervous system or brain metastases at screening (except for patients who have discontinued systemic corticosteroid treatment at least 4 weeks prior to baseline and have been stable for at least 4 weeks)
• F. Hematologic malignancy including lymphoma at screening
• G. Uncontrolled hypertension (systolic blood pressure \[SBP\]/diastolic blood pressure \[DBP\] ≥160/100 mmHg) at screening
• H. Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders at screening
• I. Active hepatitis B\* or C† at screening
• \* Defined as HBsAg positive at screening; patients on stable antiviral regimen may participate
• † Defined as HCV Ab positive at screening; patients who test negative for HCV RNA may participate
• J. Known human immunodeficiency virus (HIV) infection
• K. Difficulty (e.g., problem swallowing) in oral administration of KN510 and KN713 or disease (celiac disease, Crohn's disease, or intestinal resection which is clinically significant or impacts absorption) which impacts absorption at screening

Sponsors & Collaborators

• New Cancer Cure-Bio Co.,Ltd.: lead

Study Sites (1)

National Cancer Center

Goyang-si, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 25, 2023
• Study Start: September 11, 2023
• Primary Completion: November 5, 2024
• Study Completion: December 16, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

KR (1)