RO7444973 for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale Cancer Center; Medical Oncology, New Haven, CTSolid TumorsRO7444973 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: From baseline to death from any cause (up to 40 months)

Month 40
Overall Survival (OS)
Month 13
Change from Baseline in Percentage of Participants Positive for Anti-drug Antibodies (ADA) to RO7444973
Pharmacokinetics (PK): Serum Concentration of RO7444973 Over Time
Month 40
Progression-free Survival (PFS)
Month 12
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Day 28
Number of Participants With Dose-limiting Toxicities (DLTs)
Month 15
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Month 40
Duration of Response (DoR)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Part I: Single Participant Cohort (SPC) Dose Escalation
1 of 3
Part II: Multiple Participant Cohort (MPC) Dose Escalation
1 of 3
Part III: Recommended Phase 2 Dose (RP2D) Expansion
1 of 3

Experimental Treatment

260 Total Participants · 3 Treatment Groups

Primary Treatment: RO7444973 · No Placebo Group · Phase 1

Part I: Single Participant Cohort (SPC) Dose EscalationExperimental Group · 2 Interventions: Tocilizumab, RO7444973 · Intervention Types: Drug, Drug
Part II: Multiple Participant Cohort (MPC) Dose EscalationExperimental Group · 2 Interventions: Tocilizumab, RO7444973 · Intervention Types: Drug, Drug
Part III: Recommended Phase 2 Dose (RP2D) ExpansionExperimental Group · 2 Interventions: Tocilizumab, RO7444973 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to death from any cause (up to 40 months)

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,369 Previous Clinical Trials
1,068,290 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,152 Previous Clinical Trials
875,932 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 12 more weeks.
You are willing to use birth control if needed.
You have a type of cancer that cannot be removed through surgery and has spread to other parts of your body. You have already received standard treatments for this type of cancer and there are no other available options.
You don't have rapidly progressing cancer that can damage your vital organs. Also, you don't have any large tumors in important areas that have not been treated with radiation therapy.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.