What side effects are associated with this type of intervention?

Common treatments for Hepatocellular Carcinoma (HCC) similar to those in the RO7502175 trial include immunotherapy and targeted therapy. Immunotherapy, such as immune checkpoint inhibitors, can cause side effects like fatigue, rash, diarrhea, and immune-related adverse events affecting organs like the liver, lungs, and endocrine glands. Targeted therapies, such as sorafenib, often result in side effects including diarrhea, hand-foot skin reaction, hypertension, fatigue, and transient liver function derangement. Both treatment types aim to manage HCC but come with a range of potential adverse effects that need to be monitored.

What prior FDA approvals exist?

The FDA has approved several immunotherapies and targeted therapies for the treatment of hepatocellular carcinoma (HCC). Notable approvals include sorafenib (Nexavar), a multitargeted tyrosine kinase inhibitor, and lenvatinib (Lenvima), another tyrosine kinase inhibitor. Immunotherapy options include nivolumab (Opdivo) and pembrolizumab (Keytruda), both of which are immune checkpoint inhibitors targeting PD-1. Additionally, the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) has been approved for HCC, representing a significant advancement in immunotherapy for this cancer type.

What other types of research exist?

Promising novel alternatives to RO7502175 for Hepatocellular Carcinoma patients include: 1) Atezolizumab plus Bevacizumab, which has shown efficacy in the IMbrave 050 trial for high-risk HCC after curative resection or ablation. 2) Cabozantinib and Nivolumab, which have demonstrated potential in converting locally advanced HCC into resectable disease with enhanced antitumor immunity. 3) Antiviral therapy with nucleos(t)ide analogs, which has been shown to significantly reduce the risk of HCC recurrence and overall mortality in patients with HBV-related HCC.

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Monoclonal Antibodies

RO7502175 + Atezolizumab for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

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 up to approximately 5 years

Awards & highlights

Summary

This trial tests a new drug to see if it's safe and effective in treating multiple cancers.

Who is the study for?

This trial is for adults with certain advanced solid tumors who have a good performance status, measurable disease, and a life expectancy of at least 12 weeks. They must not be pregnant or breastfeeding, have untreated brain metastases, recent cancer treatments, active hepatitis B/C or tuberculosis, HIV infection, autoimmune diseases or live vaccine administration within the last month.Check my eligibility

What is being tested?

The study tests RO7502175 alone and combined with Atezolizumab in patients with various solid tumors. It's conducted in two parts: first to find the right dose (dose escalation) and then to see how well it works at that dose (dose expansion).See study design

What are the potential side effects?

Possible side effects include reactions related to infusion of the drugs, potential immune system-related issues due to Atezolizumab's action on the body's defenses against cancer cells as well as general drug side effects like fatigue and digestive disturbances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)

Phase Ia: Number of Participants with Treatment Emergent Adverse Events

Phase Ib: Number of Participants with DLTs

+1 more

Secondary outcome measures

Phase Ia and Phase Ib: Duration of Response (DOR)

Serum

Phase Ia and Phase Ib: Objective Response Rate (ORR)

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase Ib: ExpansionExperimental Treatment2 Interventions

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group II: Phase Ib: Dose EscalationExperimental Treatment2 Interventions

Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group III: Phase Ia: ExpansionExperimental Treatment1 Intervention

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group IV: Phase Ia: Dose EscalationExperimental Treatment1 Intervention

Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hepatocellular Carcinoma (HCC) include immunotherapy and targeted therapy. Immunotherapy, such as immune checkpoint inhibitors, works by enhancing the body's immune system to recognize and attack cancer cells. Targeted therapy involves drugs that specifically target molecular pathways critical for cancer cell growth and survival, such as tyrosine kinase inhibitors that block signals needed for tumor growth. These treatments are crucial for HCC patients as they offer more precise and potentially less toxic options compared to traditional chemotherapy, improving outcomes and quality of life.

Hepatocellular Carcinoma: Molecular Mechanisms and Targeted Therapies.

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Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,542 Previous Clinical Trials

567,682 Total Patients Enrolled

11 Trials studying Hepatocellular Carcinoma

537 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05581004 — Phase 1

Hepatocellular Carcinoma Research Study Groups: Phase Ia: Expansion, Phase Ia: Dose Escalation, Phase Ib: Expansion, Phase Ib: Dose Escalation

Hepatocellular Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05581004 — Phase 1

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05581004 — Phase 1

Hepatocellular Carcinoma Patient Testimony for trial: Trial Name: NCT05581004 — Phase 1

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