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RO7070179

Phase 1

Carcinoma, Hepatocellular | Small molecule | Oncology |Roche Holding AG|Last Updated: Feb 15, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

RO7070179 · 1 trial · 1 indication

Phase 1 1
NCT02564614A Study of Hypoxia-inducible Factor 1a (HIF1A) Messenger Ribonucleic Acid (mRNA) Antagonist (RO7070179), to Demonstrate Proof-of-mechanism in Adult Participants With Hepatocellular Carcinoma (HCC)Carcinoma, Hepatocellular
COMPLETED9 Analytics
PHASE1COMPLETED
A Study of Hypoxia-inducible Factor 1a (HIF1A) Messenger Ribonucleic Acid (mRNA) Antagonist (RO7070179), to Demonstrate Proof-of-mechanism in Adult Participants With Hepatocellular Carcinoma (HCC)
Carcinoma, HepatocellularUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to Week 6 in HIF1A mRNA Level in Tumor Tissue
Pre-dose (baseline) and Week 6

Secondary Endpoints

Change From Baseline to Week 6 in hypoxia-inducible factor 1a (HIF1A) Tumor Concentrations
Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in HIF2 Tumor Concentrations
Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in Vascular Endothelial Growth Factor (VEGF) Tumor Concentrations
Pre-dose (baseline) and Week 6
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7070179EXPERIMENTALParticipants will receive RO7070179, 13 mg/kg/week, 2-hour IV infusion every week in a 6-week cycle, after two loading doses in Week 1 of Cycle 1 on Day 1 and Day 4. If a dose-limiting toxicity (DLT) occurs in more than 33% of participants at any time, the dose will be reduced to 10 mg/kg/week. The dose will be further reduced to 6 mg/kg/week if more than 33% of treated participants have a DLT.

Interventions

NameTypeDescription
RO7070179DRUGRO7070179 (13 mg/kg/week) will be administered as 2-hour IV infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Male or female of \>=18 years of age with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1, Child-Pugh score of 5-7, and Life expectancy of 3 months or greater. * Confirmed to have HCC as described by the American Association for the Study of Liver Disease ...

Countries:United States
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Frequently asked questions about RO7070179

What is RO7070179 used for?

RO7070179 is an investigational small molecule being studied for the treatment of hepatocellular carcinoma (HCC), a type of liver cancer. It is designed to target HIF1A messenger ribonucleic acid (mRNA) as an antagonist, with the goal of demonstrating proof-of-mechanism in adult patients with HCC.

What does RO7070179 target?

RO7070179 targets hypoxia-inducible factor 1a (HIF1A) messenger ribonucleic acid (mRNA). It acts as an antagonist to HIF1A mRNA, which is a key factor in cellular response to low oxygen conditions and is often implicated in tumor growth and progression.

Who makes RO7070179?

RO7070179 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical research on this investigational drug for hepatocellular carcinoma, and the company is publicly traded under the ticker RHHBY.

What phase is RO7070179 in?

RO7070179 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety, tolerability, and mechanism of action in patients.

What clinical trials is RO7070179 in?

RO7070179 has been studied in one completed Phase 1 clinical trial, identified as NCT02564614. This trial was an uncontrolled, non-randomized study conducted in the United States, enrolling 9 adult participants with hepatocellular carcinoma to evaluate the drug's proof-of-mechanism.

Is RO7070179 the same as HIF1A mRNA antagonist?

RO7070179 is a hypoxia-inducible factor 1a (HIF1A) messenger ribonucleic acid (mRNA) antagonist. The drug is designed to inhibit HIF1A mRNA, and it is being investigated for its potential role in treating hepatocellular carcinoma by targeting this specific molecular pathway.