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Monoclonal Antibodies

RO7283420 for Acute Myeloid Leukemia

Q: Has the drug RO7283420 been tested in prior clinical studies?

<p>RO7283420 was initially studied in 2002 at Manitoba Blood &#x26; Marrow <a href="https://www.withpower.com/clinical-trials/transplant">Transplant</a> Program CancerCare Manitoba, leading to a total of 2197 completed studies. At present, 761 active clinical trials are utilizing this medication; many of these experiments are being conducted in Toronto, Ontario.</p>

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 up to approximately 4 years

Awards & highlights

Study Summary

This trial will test a new drug for safety, how it works in the body, and what side effects it causes in people with AML.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events (AEs)

Percentage of Participants with Dose-Limiting Toxicities (DLTs)

Recommended Phase II Dose (RP2D)

Secondary outcome measures

Area Under the Curve (AUC) of RO7283420

Clearance (Cl) of RO7283420

Duration of Response (DoR)

+13 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part C: Dose ExpansionExperimental Treatment6 Interventions

Participants will receive the respective RP2D for Group I and Group II.

Group II: Part B: Multiple Participant Dose EscalationExperimental Treatment6 Interventions

Multiple-participant cohorts of >= 3 participants will be enrolled for dose escalation for Group I and Group II independently. Participants will be administered a starting dose of 0.15 mg or highest dose administered in Part A. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, every-2-weeks (Q2W), or once-a-week (QW) dosing regimens, respectively to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Additionally, step-up dosing regimens with more frequent administrations of RO7283420 during cycle 1 will be evaluated.

Group III: Part A: Single Participant Dose EscalationExperimental Treatment6 Interventions

Participants from Group I will receive escalating doses of RO7283420, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1) for up to 6 cycles with a starting dose of 0.15mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Dasatinib

2012

Completed Phase 3

~2320

Dexamethasone

2007

Completed Phase 4

~2590

RO7283420

2020

Completed Phase 1

~60

Diphenhydramine

2002

Completed Phase 4

~1170

Paracetamol/acetaminophen

2020

Completed Phase 1

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,827 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,544 Total Patients Enrolled

Media Library

RO7283420 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04580121 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Part A: Single Participant Dose Escalation, Part B: Multiple Participant Dose Escalation, Part C: Dose Expansion

Acute Myeloid Leukemia Clinical Trial 2023: RO7283420 Highlights & Side Effects. Trial Name: NCT04580121 — Phase 1

RO7283420 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04580121 — Phase 1

Frequently Asked Questions

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

Has the regulatory agency sanctioned RO7283420 for clinical use?

"Due to it being a Phase 1 trial and with limited evidence of safety or efficacy, our team at Power gave RO7283420 a score of 1."

Answered by AI

How many subjects are being monitored for this research endeavor?

"To carry out this trial, a total of 220 qualified patients are needed. Hoffmann-La Roche will be overseeing the study from multiple clinical sites including Princess Margaret Cancer Center in Toronto and UC Davis Comprehensive Cancer Centre in Sacramento."

Answered by AI

Are investigators still accepting volunteers for this research project?

"Affirmative, the information hosted on clinicaltrials.gov states that this trial is actively recruiting patients. Initially posted in November 4th 2020 and most recently updated as of November 4th 2022, it requires 220 volunteers from 5 distinct medical sites."

Answered by AI

What is the geographical scope of this clinical research endeavor?

"This clinical trial is recruiting participants in multiple centres, such as Princess Margaret Cancer Centre (Toronto), UC Davis Comprehensive Cancer Center (Sacramento) and City of Hope (Duarte). Additionally, there are 5 other sites involved."

Answered by AI

Has the drug RO7283420 been tested in prior clinical studies?

"RO7283420 was initially studied in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba, leading to a total of 2197 completed studies. At present, 761 active clinical trials are utilizing this medication; many of these experiments are being conducted in Toronto, Ontario."

Answered by AI

What medical maladies does RO7283420 typically address?

"RO7283420 is a commonly prescribed intervention for leukemia. Additionally, it has been approved to assist with the management of synovitis, whiplash syndrome, ophthalmia and sympathetic ailments."

Answered by AI

Recent research and studies

BloodJournal

Targeting Intracellular WT1 in AML with a Novel Rmf-peptide-mhc-specific T-cell Bispecific Antibody

Augsberger, Christian, Gerulf Hänel, Wei Xu, Vesna Pulko, Lydia Jasmin Hanisch, Angelique Augustin, John Challier, et al.. 2021. “Targeting Intracellular WT1 in AML with a Novel Rmf-peptide-mhc-specific T-cell Bispecific Antibody”. Blood. American Society of Hematology. doi:10.1182/blood.2020010477.

BloodJournal

Targeting Intracellular WT1 in AML with a Novel Rmf-peptide-mhc-specific T-cell Bispecific Antibody

BloodJournal

Targeting Intracellular WT1 in AML with a Novel Rmf-peptide-mhc-specific T-cell Bispecific Antibody

clinicaltrials.govStudy

A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.

2020. "A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04580121.