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NCT04338685 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study of Biliary Tract Cancer and Liver Metastases, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 10
- Study locations
NCT04338685 is a Phase 1 study of Biliary Tract Cancer and Liver Metastases that has completed, run by Hoffmann-La Roche. The registered enrollment target is 55 participants, below the 238-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (77% lower). The trial reports 10 study locations across 3 states.
The verdict
NCT04338685, a Phase 1 study of Biliary Tract Cancer and Liver Metastases, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 10
- Study locations
Study 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 Studied
Interventions
- DRUG Tocilizumab
- DRUG RO7119929
Study Locations (10)
Other
- Rigshospitalet; Onkologisk Klinik - København Ø
- Queen Mary Hospital; Dept of Medicine - Hong Kong
- Seoul National University Hospital - Seoul
- Asan Medical Center - Seoul
- Hospital Universitari Vall d'Hebron; Oncology - Barcelona
- Clinica Universidad de Navarra Madrid; Servicio de Oncología - Madrid
- National Taiwan Uni Hospital - Taipei
- Tri-Service General Hospital - Taipei
California
- City of Hope Cancer Center - Duarte
Navarre
- Clínica Universidad de Navarra - Pamplona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2023-01-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04338685
The ClinicalTrials.gov registry entry for NCT04338685 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (77% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Biliary Tract Cancer appearing as the primary indexed condition, and to 2 interventions - of which Tocilizumab is the first listed.
NCT04338685 reports 10 study locations spanning 3 distinct geographic areas - top geographies include Other, California, Navarre.
Frequently Asked Questions
What is clinical trial NCT04338685 about?
NCT04338685 is a clinical study titled "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". 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 optim...
What is the current status of trial NCT04338685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2020-07-16. Estimated completion is 2023-01-09.
What conditions does trial NCT04338685 study?
This clinical trial studies the following conditions: Biliary Tract Cancer, Liver Metastases, Carcinoma, Hepatocellular, Secondary Liver Cancer.
What interventions are being tested in trial NCT04338685?
The interventions under investigation include: Tocilizumab (DRUG), RO7119929 (DRUG).
Who is sponsoring clinical trial NCT04338685?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04338685 being conducted?
This trial has 10 study locations across California, Navarre. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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