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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Kyungpook National University Hospital
Daegu, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
To determine the Recommended Phase 2 Dose (RP2D) for oral + IT administration
RP2D is defined as the dose at which dose escalation (oral + IT) ceases
Time frame: 24 months
To evaluate the safety and tolerability of KAT (oral, IT, and oral + IT) in subjects with HCC
Measured as the number of AEs per CTCAE and changes in laboratory values compared to baseline.
Time frame: 54 months
To evaluate the preliminary anti-tumor activity of KAT for oral + IT administration
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.
Time frame: 54 months
To assess maximum concentration (Cmax) of KAT (oral and oral + IT)
Blood samples will be drawn to determine Cmax of KAT
Time frame: 54 months
To assess median time to the maximum drug concentration (Tmax) of KAT (oral and oral + IT)
Blood samples will be drawn to determine Tmax of KAT
Time frame: 54 months
To assess half lives (T1/2) of KAT (oral and oral + IT)
Blood samples will be drawn to determine T1/2 of KAT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 54 months
To assess area under the curve (AUC) of KAT (oral and oral + IT)
Blood samples will be drawn to determine AUC of KAT
Time frame: 54 months