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Monoclonal Antibodies

RO7283420 for Acute Myeloid Leukemia

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 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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,333 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,977 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
~13 spots leftby Jun 2025
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