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Monoclonal Antibodies

RO7444973 for Solid Tumors

Phase 1

Waitlist Available

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 from baseline to death from any cause (up to 40 months)

Awards & highlights

Study Summary

This trial is testing a new drug, RO7444973, for safety and effectiveness in people with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors who carry the HLA-A*02:01 allele.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to death from any cause (up to 40 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to death from any cause (up to 40 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to death from any cause (up to 40 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 Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Dose-limiting Toxicities (DLTs)

Secondary outcome measures

Change from Baseline in Percentage of Participants Positive for Anti-drug Antibodies (ADA) to RO7444973

Disease Control Rate (DCR)

Duration of Response (DoR)

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part III: Recommended Phase 2 Dose (RP2D) ExpansionExperimental Treatment2 Interventions

Based on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III.

Group II: Part II: Multiple Participant Cohort (MPC) Dose EscalationExperimental Treatment2 Interventions

In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored.

Group III: Part I: Single Participant Cohort (SPC) Dose EscalationExperimental Treatment2 Interventions

In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,430 Previous Clinical Trials

1,089,399 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,200 Previous Clinical Trials

888,499 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA sanctioned RO7444973 for clinical application?

"The safety of RO7444973 is estimated to be a 1, since this study is in its first phase and there exists little data regarding both efficacy and security."

Answered by AI

Are there numerous sites administering this research within the city?

"This research program is being conducted by the University of Florida in Gainesville, Yale Cancer Center's Medical Oncology department located in Detroit and Henry Ford Hospital situated in Hackensack. Additionally, there are 7 other participating sites involved."

Answered by AI

What other exploratory tests have been done with RO7444973?

"At present, RO7444973 is being tested in 71 clinical trials; with 8 of those studies firmly situated within Phase 3. Though the majority are found in Poznan and New york City, there are 1455 other locations around the world conducting research on this medication."

Answered by AI

Are there any enrollments being accepted for this research endeavor at present?

"Affirmative. According to the clinicaltrials.gov website, this trial began recruitment on January 25th 2022 and is currently ongoing. A total of 260 patients are sought after across 7 medical sites."

Answered by AI

What have physicians been recommending RO7444973 for lately?

"RO7444973 is a medication primarily used to treat polyarticular juvenile idiopathic arthritis. Additionally, it can help patients with sjia, cytokine release syndrome caused by car-t cell therapy, and giant cells manage their medical conditions."

Answered by AI

What is the maximum capacity for participants in this research?

"For the trial to be considered successful, a total of 260 participants that meet the necessary prerequisites must be recruited. Hoffmann-La Roche will manage this study from two separate sites - University of Florida in Gainesville and Yale Cancer Center's Medical Oncology branch in Detroit."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors

2022. "A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05129280.