SuspendedPhase 1/2

KAT-101 in Subjects With Hepatocellular Carcinoma (HCC)

Stopped: Enrollment paused

South Korea148 participantsStarted 2022-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

To determine the Recommended Phase 2 Dose (RP2D) for oral + IT administration

Timeframe: 24 months

Trial details

NCT IDNCT05603572

SponsorPrimocure Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

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