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Advanced Solid TumorsPhase 1NCT06012708

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

A Phase 1 study testing KN510 60mg/day + KN713 60mg/day, KN510 120mg/day + KN713 60mg/day and KN510 120mg/day + KN713 90mg/day in people with Advanced Solid Tumors, run by New Cancer Cure-Bio Co.,Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
KN510 60mg/day + KN713 60mg/day, KN510 120mg/day + KN713 60mg/day and KN510 120mg/day + KN713 90mg/day
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSouth Korea
Study dates
11 Sep 2023to 16 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
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  • Hematological function
  • Absolute neutrophil count (ANC) ≥1,500/μL
  • Hemoglobin ≥9 g/dL
  • Platelet count ≥100,000/μL
  • Renal function: Creatinine clearance (CrCl*) >60 mL/min
  • Cockcroft-Gault equation
  • Hepatic function
  • Aspartate aminotransferase (AST) ≤3.0 × ULN
  • Alanine aminotransferase (ALT) ≤3.0 × ULN (AST/ALT ≤5 × ULN, if hepatic metastasis is confirmed)
  • Total bilirubin ≤1.5 × ULN (with the exception of confirmed Gilbert's syndrome)
  • Coagulation function: Prothrombin time international normalized ratio (PT INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN
  • Voluntary written consent to participate in this study

Who cannot join

  • Hypersensitivity to the active ingredient or excipients of KN510 or KN713
  • Any of the following medical (surgical) history or comorbidities at the screening visit:
  • 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)
  • Clinically significant arrhythmia, acute myocardial infarction, unstable angina, or NYHA Grade Ⅲ or Ⅳ heart failure within 24 weeks prior to screening
  • 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
  • Grade 3 or higher active infectious conditions which require systemic antibiotics, antivirals, etc. within 2 weeks prior to screening
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  • 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)
  • Hematologic malignancy including lymphoma at screening
  • Uncontrolled hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP] ≥160/100 mmHg) at screening
  • Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders at screening
  • 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
  • Known human immunodeficiency virus (HIV) infection
  • 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
  • History or suspected symptoms of gastroesophageal reflux disease (GERD) such as gastric ulcer, duodenal ulcer, and reflux esophagitis at screening
  • History of autoimmune diseases at screening
  • Deemed ineligible for the study for having a comorbidity that is uncontrolled or requires treatment
  • Prior treatment with any of the following medications within 2 weeks prior to screening
  • Proton pump inhibitors (PPIs) other than the IP
  • Strong CYP2C19 inducers: Rifampicin, Apalutamide, Rifamycin, Rifaximin, Rifapentine
  • Strong CYP2C19 inhibitors: Fluvoxamine, Ticlopidine, Chloramphenicol, Delavirdine, Gemfibrozil, Stiripentol, Fluoxetine, Imipramine, Clomipramine, Lansoprazole, Isoniazid, Zafirlukast, Tioconazole, Miconazole
  • CYP2C19 substrates: Clopidogrel, Citalopram, Cilostazol, Phenytoin, Diazepam
  • Vitamin K antagonists: Warfarin, Dicoumarol, Phenindione, Phenprocoumon, Acenocoumarol, Ethyl biscoumacetate, Fluindione, Clorindione, Diphenadione, Tioclomarol
  • Antiretrovirals: Rilpivirine-containing products, Atazanavir, Nelfinavir, Saquinavir
  • High dose Methotrexate (≥1000 mg/m2)
  • Digoxin
  • Cefditoren, Cefuroxime
  • Levoketoconazole
  • St John's Wort
  • Bromopride, Metoclopramide
  • Other anti-cancer therapies (chemotherapy, radiotherapy, immunotherapy, targeted therapy, hormone therapy, etc. other than the IP) which could impact the efficacy results during the study (However, local radiotherapy to alleviate ostalgia, bronchial obstruction, skin lesion, etc. are permitted. The total irradiation dose must be within the site-specific reference range for palliative therapy, and irradiation sites must be excluded from the tumor assessment.)
  • Requiring continued treatment with systemic corticosteroids at a dose of prednisone >10 mg/day or equivalent (with exceptions of topical use such as intra-articular, intranasal, intraocular, and inhalational administration and temporary use for treatment and prevention of allergic reactions to a contrast agent or AEs [e.g., vomiting])
  • Pregnant or lactating women, or women of childbearing potential and men who are unwilling to remain abstinent or use adequate methods of contraception* during the study and for 3 months after IP administration
  • Adequate methods of contraception:
  • Hormonal contraceptives
  • Placement of an intrauterine device or intrauterine system
  • Surgical sterilization (vasectomy, tubal ligation, etc.)
  • Received/Used another investigational agent/device within 4 weeks (or 5 half-lives) prior to screening
  • Ineligibility or inability to participate in the study in the judgment of the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center

    Goyang-si

Other trials in South Korea

About this study

Official title: An Open-label, Dose-escalation and Dose-finding, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713 as Combination Therapy in Patients With Advanced Solid Tumors

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.

Read the detailed description

It is expected that KN510 and KN713 will broaden the range of target patient groups and overcome resistance to the drugs in an innovative manner by targeting the common metabolic process of cancer cells, unlike existing targeted therapies whose application is limited depending on the presence of specific mutation and combination of mutations as they mainly target a single tyrosine kinase.

In this study, the safety and tolerability of combination therapy of KN510 and KN713, including the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), will be evaluated in patients with advance solid tumors and based on this, the recommended phase 2 dose (RP2D) will be determined.

Being tested
KN510 60mg/day + KN713 60mg/day, KN510 120mg/day + KN713 60mg/day, KN510 120mg/day + KN713 90mg/day, KN510 120mg/day + KN713 120mg/day
Keywords
Advanced solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KN510 60mg/day + KN713 60mg/dayDrug

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

  • KN510 120mg/day + KN713 60mg/dayDrug

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

  • KN510 120mg/day + KN713 90mg/dayDrug

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

  • KN510 120mg/day + KN713 120mg/dayDrug

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

Study groups in NCT06012708
Study groupRoleWhat they receive
Dose Level 1ExperimentalNot described
Receives: Drug: KN510 60mg/day + KN713 60mg/day
Dose Level 2ExperimentalNot described
Receives: Drug: KN510 120mg/day + KN713 60mg/day
Dose Level 3ExperimentalNot described
Receives: Drug: KN510 120mg/day + KN713 90mg/day
Dose Level 4ExperimentalNot described
Receives: Drug: KN510 120mg/day + KN713 120mg/day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Until 28 days from the first IP administration

  2. AEs(Adverse Events)

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

    Measured: Through study completion, an average of 5 months

  3. Laboratory tests

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

    Measured: Through study completion, an average of 5 months

  4. Vital signs

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

    Measured: Through study completion, an average of 5 months

  5. 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.

    Measured: Through study completion, an average of 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2023
  2. Study start11 Sep 2023
  3. Primary completion5 Nov 2024
  4. Study completion16 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06012708
Sponsor's protocol ID
NCCKN-101
Status last verified
Jan 2025
First submitted
4 Aug 2023
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Choi W, Chun JW, Sim SH, Han SS, Lee WJ, Kang JH, Kim HC, Lee S, Lee JH, Yoo HJ, Kim SY, Woo SM. Phase 1 Study of Safety and PK With A Combination of Omeprazole and Trimetazidine for Fatty Acid Oxidation Inhibition in Patients With Advanced Solid Tumors. Clin Transl Sci. 2026 Nov;19(11):e70752. doi: 10.1111/cts.70752.

    PubMed 42951875

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KN510 60mg/day + KN713 60mg/day, KN510 120mg/day + KN713 60mg/day and KN510 120mg/day + KN713 90mg/day in people with Advanced Solid Tumors, run by New Cancer Cure-Bio Co.,Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT(dose limiting toxicity) (time frame: Until 28 days from the first IP administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06012708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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