NCT05603572

KAT-101 in Subjects With Hepatocellular Carcinoma (HCC)

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

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Primocure Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• Fibrolamellar Carcinoma

Interventions

Type	Name	Description
DRUG	KAT-101	oral dosage form
DRUG	KAT-201	IT dosage form

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2022-11-02
• Last updated: 2025-06-05

Locations

3 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study