KAT-101 in Subjects With Hepatocellular Carcinoma (HCC)

Trial Title: KAT-101 in Subjects With Hepatocellular Carcinoma (HCC)

NCT ID: NCT05603572

Condition: Hepatocellular Carcinoma
Fibrolamellar Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: 1. Oral administration (KAT-101) 2. IT administration (KAT-201) 3. Oral administration (KAT-101) + IT administration (KAT-201)

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: KAT-101
Description: oral dosage form
Arm group label: Oral + IT experimental arm
Arm group label: Oral experimental arm

Intervention type: Drug
Intervention name: KAT-201
Description: IT dosage form
Arm group label: IT experimental arm
Arm group label: Oral + IT experimental arm

Summary: 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.

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.

Criteria for eligibility:
Criteria:
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: 1. Major surgery within 28 days 2. Radiotherapy within 14 days including palliative radiation 3. Use of steroids (except for topical agents) within 14 days 4. Chemotherapy within 3 weeks (6 weeks for nitrosourea compounds) 5. Prior treatment with biologic agents, including hormone therapy, within the last 3 weeks, or at least 5 half-lives, whichever is shorter 6. Tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver 7. Treatment with another investigational product within 4 weeks prior to screening or for which 5 half-lives have not elapsed, whichever is longer 8. 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kyungpook National University Hospital

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Country: Korea, Republic of

Start date: November 1, 2022

Completion date: November 2025

Lead sponsor:
Agency: Primocure Pharma
Agency class: Industry

Source: Primocure Pharma

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05603572