Clinical trial NCT03645980: DKN-01 Inhibition in Advanced Liver Cancer
Official title: A Phase I/II Multicenter, Open-label Study of DKN-01 to Investigate the Anti-tumor Activity and Safety of DKN-01 in Patients With Hepatocellular Carcinoma and WNT Signaling Alterations
Conditions: Hepatocellular Carcinoma
Summary: This clinical trial is a prospective, open label, single arm oncological phase I/II trial in patients with hepatocellular carcinoma and WNT signaling alterations. The trial consists of two parts: Part A is a phase I study investigating the safety of DKN-01 administered as mono- as well as combination therapy with sorafenib in a 2 step dose escalation.Part B is a phase II study to investigate the anti-tumor activity and safety of DKN-01 in patients with advanced HCC. DKN-01 is administered at the recommend phase II dose (RP2D) for monotherapy and at the recommend phase II dose for combination therapy established in Part A.
Interventions:
description: DKN-01 will be administered intravenous (IV) over a minimum of 30 minutes and up to a maximum of 2 hours given on days 1 and 15 of each 28 day cycle.
name: DKN-01 300 mg
type: Drug
description: DKN-01 will be administered intravenous (IV) over a minimum of 30 minutes and up to a maximum of 2 hours given on days 1 and 15 of each 28 day cycle.
name: DKN-01 600 mg
type: Drug
description: For combination with DKN-01, sorafenib will be administrated according to standard clinical practice. Part A: After 8 weeks monotherapy with DKN-01, the study will be continued as combination therapy of DKN-01 and sorafenib until objective disease progression (PD) or unacceptable toxicity occurs. Part B:After PD1, study treatment will be continued as combination therapy of DKN-01 and sorafenib until disease progression (PD2) or unacceptable toxicity occurs.
name: Sorafenib
type: Drug
Study arms:
design_group_description: Phase I Study treatment will be started as monotherapy with DKN-01 for up to 8 weeks or until unacceptable toxicity occurs. The study will be continued as combination therapy of DKN-01 and sorafenib until objective disease progression (PD) or unacceptable toxicity occurs. The dose of DKN-01 for cohort 1 will be 300 mg , depending on the results of the safety assessment. Phase II The dose of DKN-01 will be the recommended phase II dose (RP2D) determined from Part A. Study treatment will be started as monotherapy with DKN-01 until objective disease progression (PD1) or unacceptable toxicity occurs. After PD1, study treatment will be continued as combination therapy of DKN-01 and sorafenib until disease progression (PD2) or unacceptable toxicity occurs.
design_group_title: DKN-01 300 mg
design_group_type: Experimental
design_group_description: Phase I Study treatment will be started as monotherapy with DKN-01 for up to 8 weeks or until unacceptable toxicity occurs. The study will be continued as combination therapy of DKN-01 and sorafenib until objective disease progression (PD) or unacceptable toxicity occurs. The dose of DKN-01 for cohort 2 will be 600 mg or 150 mg, depending on the results of the safety assessment. Phase II The dose of DKN-01 will be the recommended phase II dose (RP2D) determined from Part A. Study treatment will be started as monotherapy with DKN-01 until objective disease progression (PD1) or unacceptable toxicity occurs. After PD1, study treatment will be continued as combination therapy of DKN-01 and sorafenib until disease progression (PD2) or unacceptable toxicity occurs.
design_group_title: DKN-01 600 mg
design_group_type: Experimental
Sponsor: The Johannes Gutenberg University of Mainz
Collaborators: Cypherpunk Technologies, Inc.
Drug name mappings:
name: Sirexatamab
lang: EN
name: 甲苯磺酸索拉非尼
lang: CN
name: Sorafenib Tosylate
lang: EN
name: ソラフェニブトシル酸塩
lang: JP