- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05603572
KAT-101 in Subjects With Hepatocellular Carcinoma (HCC)
November 9, 2023 updated by: NewG Lab Pharma
A Multi-center, Open-label, Phase 1/2a Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KAT-101 in Subjects With HCC
NLP-KAT-101 is a Phase 1/2a dose escalation and expansion study to investigate the safety, tolerability, PK, and preliminary efficacy of oral + intratumoral (IT) KAT in subjects with HCC.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Phase 1 will identify the optimal dose for oral alone, IT alone and the recommended Phase 2 dose (RP2D) dose for oral + IT together.
Once the RP2D is identified, additional subjects will be enrolled into Phase 2a (dose-expansion) to further investigate the efficacy and safety of oral + IT KAT at the RP2D.
Study Type
Interventional
Enrollment (Estimated)
148
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Daegu, Korea, Republic of
- Kyungpook National University Hospital
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Confirmed HCC not amenable to surgical resection or curative-intent locoregional ablative treatments and who are not eligible for liver transplantation.
- Systemic treatment-naive for unresectable locally advanced or metastatic HCC. In addition, have progressed on, refused or were intolerant to sorafenib, lenvatinib, or atezolizumab in combination with bevacizumab. A maximum of 2 prior lines of systemic therapy (including chemotherapy or targeted therapy, not including locoregional therapy) will be allowed.
- At least one measurable lesion based on RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ function
Exclusion Criteria:
Prior to the first administration of the study treatment:
- Major surgery within 28 days
- Radiotherapy within 14 days including palliative radiation
- Use of steroids (except for topical agents) within 14 days
- Chemotherapy within 3 weeks (6 weeks for nitrosourea compounds)
- Prior treatment with biologic agents, including hormone therapy, within the last 3 weeks, or at least 5 half-lives, whichever is shorter
- Tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver
- Treatment with another investigational product within 4 weeks prior to screening or for which 5 half-lives have not elapsed, whichever is longer
- Uncontrolled central nervous system (CNS) metastasis
- Any clinically significant abnormal intestinal findings that may interfere with the investigational product
- Severe cardiac disorders or subjects with comorbidities of other serious internal disorders on investigator's judgment
- QTcF > 450 msec or congenital long QT syndrome
- Suspected serious infectious diseases, intestinal paralysis, bowel obstruction, interstitial pneumonia, or pulmonary fibrosis
- Serious underlying medical or psychiatric condition, dementia or altered mental status that would impair the ability to understand informed consent, contraindicate participation in the study or confound the results of the study
- Known human immunodeficiency virus (HIV) infection or chronic or active hepatitis B virus (HBV) hepatitis C virus (HCV). Subjects with HCV who have a documented cure (undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of treatment) may be enrolled.
- Severe physical or mental trauma that results from injury or a wound(s).
- Any condition or non-removable device contraindicated for MRI examination
- Pregnant women or nursing mothers.
- Women of childbearing potential (WOCBP) who are unwilling to use a medically acceptable method of birth control during the study until 185 days after the last dose of study treatment
- Men with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the study until 95 days after the last dose of study treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral experimental arm
Oral administration (KAT-101) taken once per day for 4 consecutive days out of 7 (4 days on / 3 days off weekly).
Each cycle is 28 days.
Treatment will continue for up to 12 cycles until progressive disease (PD), unacceptable toxicity, or any reason for discontinuing its administration, whichever occurs first.
|
oral dosage form
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Experimental: IT experimental arm
IT administration (KAT-201) will be injected via percutaneous IT injection with ultrasound and/or computed tomography (CT) guidance once a week (on Day 1 weekly).
Each cycle is 28 days.
Treatment will continue for up to 2 cycles until PD, unacceptable toxicity, or any reason for discontinuing its administration, whichever occurs first.
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IT dosage form
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Experimental: Oral + IT experimental arm
Once optimal oral and IT dose are determined, oral + IT will be administered as follows: oral administration (KAT-101) will be taken once per day for 4 consecutive days out of 7 (4 days on / 3 days off weekly).
Treatment will continue for up to 12 cycles (each cycle 28 days).
IT administration (KAT-201) will be injected via percutaneous IT injection with ultrasound and/or CT guidance once a week (on Day 1 weekly).
Treatment will continue for up to 2 cycles (each cycle 28 days) until PD, unacceptable toxicity, or any reason for discontinuing its administration, whichever occurs first.
|
oral dosage form
IT dosage form
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the Recommended Phase 2 Dose (RP2D) for oral + IT administration
Time Frame: 24 months
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RP2D is defined as the dose at which dose escalation (oral + IT) ceases
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety and tolerability of KAT (oral, IT, and oral + IT) in subjects with HCC
Time Frame: 54 months
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Measured as the number of AEs per CTCAE and changes in laboratory values compared to baseline.
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54 months
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To evaluate the preliminary anti-tumor activity of KAT for oral + IT administration
Time Frame: 54 months
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Overall response rate (ORR) is defined as the proportion of subjects with a best overall response (BOR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and/or mRECIST; disease control rate (DCR), defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD); duration of response (DOR), defined as the length of time from the time of response (CR or PR) to the time of PD or death; progression-free survival (PFS), defined as the time from the date of treatment initiation to PD or death; overall survival (OS), defined as the length of time from the date of treatment initiation to death from any cause.
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54 months
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To assess maximum concentration (Cmax) of KAT (oral and oral + IT)
Time Frame: 54 months
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Blood samples will be drawn to determine Cmax of KAT
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54 months
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To assess median time to the maximum drug concentration (Tmax) of KAT (oral and oral + IT)
Time Frame: 54 months
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Blood samples will be drawn to determine Tmax of KAT
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54 months
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To assess half lives (T1/2) of KAT (oral and oral + IT)
Time Frame: 54 months
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Blood samples will be drawn to determine T1/2 of KAT
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54 months
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To assess area under the curve (AUC) of KAT (oral and oral + IT)
Time Frame: 54 months
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Blood samples will be drawn to determine AUC of KAT
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54 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
October 23, 2022
First Submitted That Met QC Criteria
October 30, 2022
First Posted (Actual)
November 2, 2022
Study Record Updates
Last Update Posted (Estimated)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NLP-KAT-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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