What is the mechanism of action of this treatment?

RO7589831, a Werner (WRN) protein inhibitor, targets the WRN protein involved in DNA repair and replication, aiming to block the growth of tumors with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR). This targeted approach is crucial for patients with these specific tumor types as it offers a potentially more effective treatment. Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells; immunotherapy, which enhances the immune system's ability to fight cancer; and targeted therapies that inhibit specific molecules driving tumor growth. Understanding these mechanisms allows for personalized treatment strategies, improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, especially those targeting specific proteins or pathways like the Werner (WRN) protein inhibitor RO7589831, often include targeted therapies and immunotherapies. These treatments can cause a range of side effects. Targeted therapies may lead to skin issues, diarrhea, liver problems, and high blood pressure. Immunotherapies, such as anti-PD-1 or anti-CTLA-4 therapies, can cause immune-related side effects including fatigue, rash, diarrhea, and inflammation of organs like the lungs (pneumonitis) or liver (hepatitis). It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors. These include PARP inhibitors like niraparib and rucaparib, which are used in cancers with homologous recombination repair deficiencies, such as BRCA mutations. Additionally, pembrolizumab, an immune checkpoint inhibitor, has been approved for various solid tumors, including melanoma and head and neck cancers. These treatments work by targeting specific pathways or proteins involved in tumor growth and survival, similar to the investigational WRN protein inhibitor RO7589831.

What other types of research exist?

Promising alternatives to RO7589831 for solid tumor patients include: 1) Nur77-derived Bcl-2 converting peptide, which induces apoptosis and suppresses tumor growth in chemoresistant lung cancer cells. 2) BI2536, a Plk1 inhibitor that represses the androgen signaling pathway in castration-resistant prostate cancer. 3) Lutetium Lu 177 vipivotide tetraxetan, which has shown clinical efficacy in metastatic castration-resistant prostate cancer. These treatments target different mechanisms and have demonstrated potential in clinical or preclinical studies.

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Monoclonal Antibodies

RO7589831 for Solid Tumors

Phase 1

Recruiting

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 at prespecified timepoints in cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)

Awards & highlights

Study Summary

This trial tests a new drug for advanced solid tumors, to see if it's safe and effective.

Who is the study for?

This trial is for adults with advanced solid tumors that are microsatellite instability (MSI) and/or deficient mismatch repair (dMMR). Participants must have measurable disease, be in good general health with a performance status score of 0 or 1, and have tried at least one standard treatment without success. They should not have any major infections, uncontrolled diabetes, CNS metastases requiring steroids or anticonvulsants, or known Werner syndrome.Check my eligibility

What is being tested?

The study tests RO7589831, an oral drug targeting the WRN protein to potentially stop the growth of MSI/dMMR cancers. It's a Phase I trial involving dose-escalation and expansion to assess safety, tolerability, how the body processes the drug (pharmacokinetics), its effects on cancer cells (pharmacodynamics), and initial effectiveness against tumors.See study design

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions to new cancer drugs such as nausea, fatigue, allergic reactions to ingredients in the pill form of RO7589831. Since it's a first-in-human study assessing safety/tolerability is a primary goal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at prespecified timepoints in cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at prespecified timepoints in cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at prespecified timepoints in cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 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

Incidence of Adverse Events, with Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)

Incidence of Dose-Limiting Toxicities

Secondary outcome measures

Apparent Oral Clearance (CL/F) of RO7589831

Area Under the Plasma Concentration-Time Curve (AUC) of RO7589831

Disease Control Rate

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part II: RO7589831 Dose ExpansionExperimental Treatment1 Intervention

Group II: Part I: RO7589831 Dose EscalationExperimental Treatment1 Intervention

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

RO7589831, a Werner (WRN) protein inhibitor, targets the WRN protein involved in DNA repair and replication, aiming to block the growth of tumors with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR). This targeted approach is crucial for patients with these specific tumor types as it offers a potentially more effective treatment. Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells; immunotherapy, which enhances the immune system's ability to fight cancer; and targeted therapies that inhibit specific molecules driving tumor growth. Understanding these mechanisms allows for personalized treatment strategies, improving patient outcomes.

Transcription factor POU6F1 is important for proliferation of clear cell adenocarcinoma of the ovary and is a potential new molecular target.

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Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,434 Previous Clinical Trials

1,091,172 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,202 Previous Clinical Trials

889,816 Total Patients Enrolled

~147 spots leftby Dec 2025

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