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Monoclonal Antibodies

Dose Escalation Cohort for Metastatic Tumor

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 39 months

Awards & highlights

Study Summary

This trial is the first time a new drug called RO7566802 is being tested on humans. The study will look at how safe and effective the drug is, both by itself and when used with

Who is the study for?

This trial is for adults with advanced solid tumors that have grown despite treatment, or when standard treatment isn't suitable. Participants should be in good physical condition (ECOG 0-1), expected to live at least 3 months, and have proper organ function. They must provide a tumor sample if needed.Check my eligibility

What is being tested?

The study tests RO7566802 alone and combined with Atezolizumab to assess safety and early cancer-fighting ability. It's a two-stage process: first finding the right dose (dose escalation) then seeing how well it works (expansion).See study design

What are the potential side effects?

Possible side effects include typical reactions to immunotherapy like fatigue, skin reactions, inflammation of organs, flu-like symptoms, changes in blood counts or chemistry which could indicate liver or kidney issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 39 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 39 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 39 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

Number of Participants with DLTs

Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)

Secondary outcome measures

Area Under the Serum Concentration Time Curve (AUC) of RO7566802

Maximum Serum Concentration (Cmax) of RO7566802

Minimum Serum Concentration (Cmin) of RO7566802

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion CohortExperimental Treatment2 Interventions

Participants with select solid tumors will receive a recommended dose of RO7566802, determined in 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: Dose Escalation CohortExperimental Treatment2 Interventions

Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 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.

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

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,541 Previous Clinical Trials

567,841 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,353 Total Patients Enrolled

Frequently Asked Questions

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

What is the upper limit on the number of individuals involved in this clinical study?

"A total of 250 eligible individuals are required to enroll in this research study. Participants have the option to take part at diverse sites like Peter Maccallum Cancer Centre in Melbourne, Victoria and St Vincent's Hospital Sydney in Darlinghurst, New South Wales."

Answered by AI

Has the Dose Escalation Cohort received approval from the FDA?

"Our team at Power rated the safety of Dose Escalation Cohort as a 1 on the scale from 1 to 3. This assessment is based on it being a Phase 1 trial, which implies scarce evidence backing both safety and effectiveness."

Answered by AI

Is the enrollment for this research study currently open?

"According to the details provided on clinicaltrials.gov, patient recruitment is ongoing for this medical research investigation. The trial was originally published on November 27th, 2023, with the latest update recorded on April 10th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

2023. "A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06031441.