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 Tumours With Hepatic Metastases

Titre officiel

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 Tumours With Hepatic Metastases

Sommaire:

Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumours 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.

Description de l'essai

Primary Outcome:

• Nature and Frequency of Dose-Limiting Toxicities
• Number of Participants with Adverse Events (AEs) According To NCI CTCAE v5.0

• Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929
• Maximum Concentration (Cmax) for RO7117418 Following Administration of RO7119929
• Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929
• Time of Maximum Concentration Observed (Tmax) for RO7117418 Following Administration of RO7119929
• Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929
• Area Under the Curve (AUC) for RO7117418 Following Administration of RO7119929
• Half-Life (T1/2) for RO7119929 Following Administration of RO7119929
• Half-Life (T1/2) for RO7117418 Following Administration of RO7119929
• Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929 in Fasting Conditions
• Maximum Concentration (Cmax) for RO7117418 Following Administration of RO7119929 in Fasting Conditions
• Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929 in Fasting Conditions
• Time of Maximum Concentration Observed (Tmax) for RO7117418 Following Administration of RO7119929 in Fasting Conditions
• Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929 in Fasting Conditions
• Area Under the Curve (AUC) for RO7117418 Following Administration of RO7119929 in Fasting Conditions
• Half-Life (T1/2) for RO7119929 Following Administration of RO7119929 in Fasting Conditions
• Half-Life (T1/2) for RO7117418 Following Administration of RO7119929 in Fasting Conditions
• Change in Inflammatory PD Biomarker INF-alpha
• Change in Inflammatory PD Biomarker ISGs
• Objective Response Rate (ORR) according to RECIST v1.1
• Disease Control Rate (DCR) according to RECIST v1.1
• Duration of Response (DOR) according to RECIST v1.1
• Progression-Free Survival (PFS) according to RECIST v1.1
• Overall Survival (OS)

Voir cet essai sur ClinicalTrials.gov