NCT04338685

A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases

A First In Human, Open Label, Dose Escalation Phase I Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Clinical Activity Profile Of Single Agent RO7119929 (TLR7 Agonist) Administered Orally To Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement. The primary objective of the study is to explore the safety and to determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) of RO7119929 as single agent.

Conditions

• Carcinoma, Hepatocellular
• Biliary Tract Cancer
• Secondary Liver Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	RO7119929	RO7119929 will be administered orally as a capsule
DRUG	Tocilizumab	Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome. Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants \> 30 kg: 8 mg/kg, for participants \< 30 kg: 12mg/kg IV

Timeline

• Start date: 2020-07-16
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2020-04-08
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

10 sites across 6 countries: United States, Denmark, Hong Kong, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study