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Virus Therapy

RO7119929 for Hepatocellular Carcinoma

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 14 months

Awards & highlights

Study Summary

This trial is testing a new drug, RO7119929, as a possible treatment for primary liver cancer and other cancers that have spread to the liver. The goal is to find out what dose is safe and how well the drug works.

Eligible Conditions

Liver Metastases
Hepatocellular Carcinoma
Biliary Tract Cancer
Liver Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Nature and Frequency of Dose-Limiting Toxicities

Number of Participants with Adverse Events (AEs) According To NCI CTCAE v5.0

Secondary outcome measures

Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929

Disease Control Rate (DCR) according to RECIST v1.1

Half-Life (T1/2) for RO7119929 Following Administration of RO7119929

+5 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part B1-5 mg RO7119929Experimental Treatment1 Intervention

Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12

Group II: Part A3-4 mg RO7119929Experimental Treatment2 Interventions

Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles

Group III: Part A2- 2/5/6 mg RO7119929Experimental Treatment1 Intervention

Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1.

Group IV: Part A2- 2/5/5 mg RO7119929Experimental Treatment1 Intervention

Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1.

Group V: Part A1-3 mg RO7119929Experimental Treatment1 Intervention

Participants received 4 mg RO7119929 every week in 3-week cycles

Group VI: Part A1-1 mg RO7119929Experimental Treatment1 Intervention

Participants received 1mg RO7119929 every week in 3-week cycles.

Group VII: Part A1 -9 mg RO7119929Experimental Treatment1 Intervention

Participants received 9 mg RO7119929 every week in 3-week cycles

Group VIII: Part A1 - 6 mg RO7119929Experimental Treatment1 Intervention

Participants received 6 mg RO7119929 every week in 3-week cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RO7119929

2020

Completed Phase 1

~60

Tocilizumab

2012

Completed Phase 4

~1840

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,430 Previous Clinical Trials

1,089,355 Total Patients Enrolled

7 Trials studying Hepatocellular Carcinoma

5,338 Patients Enrolled for Hepatocellular Carcinoma

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,677 Total Patients Enrolled

4 Trials studying Hepatocellular Carcinoma

5,260 Patients Enrolled for Hepatocellular Carcinoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications does RO7119929 typically address?

"RO7119929 is often prescribed to treat polyarticular juvenile idiopathic arthritis. Beyond this, the drug has seen success in managing systemic juvenile idiopathic arthritis (sjia), cytokine release syndrome triggered by car-t cell therapy, and giant cells."

Answered by AI

Are there any vacancies for participants in this research trial?

"Unfortunately, clinicaltrials.gov reports that no new participants are being enrolled at this point in time; the trial was first posted on July 16th 2020 and last updated October 26th 2022. Nevertheless, there remain 3361 medical studies actively seeking volunteers right now."

Answered by AI

What is the current participant capacity for this trial?

"At the moment, this medical trial is not actively seeking out participants. Initially posted on July 16th 2020, and updated as recently October 26th 2022; if you are in search of other studies for your condition, there are currently 3290 trials searching for those with carcinoma or hepatocellular cases - including 71 that require RO7119929 patients."

Answered by AI

Is there any precedent of RO7119929 being tested in a medical experiment?

"At the moment, 71 studies for RO7119929 are ongoing, 8 of which have reached Phase 3. Though a majority of research sites are situated in Poznan and New york City, there is a global network encompassing 1455 clinics running trials for this drug."

Answered by AI

What potential health risks might be associated with RO7119929?

"Our experts at Power rated RO7119929's safety a 1 out of 3 as this is an early-phase clinical trial with limited data on both efficacy and toxicity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04338685.