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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

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Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,941 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,658 Total Patients Enrolled

Frequently Asked Questions

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

Is it possible to join the current iteration of this research?

"Affirmative. According to records hosted on clinicaltrials.gov, this medical experiment is currently enrolling participants. It was first posted on October 15th 2023 and updated just recently on September 28th of the same year. This trial requires the recruitment of 220 individuals from 2 distinct study sites."

Answered by AI

What is the upper limit to how many participants can take part in this research?

"Confirmed. Clinicaltrials.gov's data indicate that recruitment is ongoing for this trial which was initially posted on October 15th, 2023 and recently updated on September 28th of the same year. 220 individuals are needed from two distinct medical sites."

Answered by AI

What potential hazards should be taken into account when considering Part I: RO7589831 Dose Escalation?

"It is expected that Part I: RO7589831 Dose Escalation will be safe, as evidenced by its score of 1. This reflects the limited information available on safety and efficacy in a Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors

2024. "A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004245.