RO7283420 for Leukemia, Myeloid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Leukemia, Myeloid+3 More
RO7283420 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Leukemia, Myeloid
  • Leukemia, Myelocytic, Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

3 Primary · 18 Secondary · Reporting Duration: From baseline up to approximately 4 years

Day 21
Area Under the Curve (AUC) of RO7283420
Clearance (Cl) of RO7283420
Half-life (T1/2) of RO7283420
Maximum Concentration (Cmax) of RO7283420
Minimum Concentration (Cmin) of RO7283420
Volume (V) of RO7283420
Day 21
Incidence and Titer of Anti-drug Antibodies (ADA) against RO7283420
Year 4
Progression-free Survival (PFS)
Day 60
Early Mortality Rate
Year 4
Event-free Survival (EFS)
From baseline until the time of documented hematological relapse
Time to Hematological Relapse (Group II Only)
Day 28
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Month 7
Maximum Reduction (%) from Baseline in Blast Count in Peripheral Blood and/or Bone Marrow
Maximum Reduction (%) from Baseline in Blast Count in Peripheral Blood and/or Bone Marrow (Group I Dose Escalation Cohorts only)
Number of MRD (Measurable Residual Disease) Negative Participants over time According to Local MRD Assessment
Percentage of Participants with >= 50% Reduction from Baseline in Blast Count in Peripheral Blood and/or Bone Marrow
Recommended Phase II Dose (RP2D)
Blood Transfusion
Month 9
Percentage of Participants with Adverse Events (AEs)
Year 4
Percentage of Participants who Achieve a Response
Year 4
Duration of Response (DoR)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

6 Treatment Groups

Part C: Dose Expansion
1 of 6
Part B: Multiple Participant Dose Escalation
1 of 6
Part A: Single Participant Dose Escalation
1 of 6
RO7283420 Part B
1 of 6
RO7283420 Part A
1 of 6
RO7283420 Part C
1 of 6

Experimental Treatment

220 Total Participants · 6 Treatment Groups

Primary Treatment: RO7283420 · No Placebo Group · Phase 1

Part C: Dose ExpansionExperimental Group · 6 Interventions: Dasatinib, Dexamethasone, Tocilizumab, RO7283420, Diphenhydramine, Paracetamol/acetaminophen · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Part B: Multiple Participant Dose EscalationExperimental Group · 6 Interventions: Dasatinib, Dexamethasone, Tocilizumab, RO7283420, Diphenhydramine, Paracetamol/acetaminophen · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Part A: Single Participant Dose EscalationExperimental Group · 6 Interventions: Dasatinib, Dexamethasone, Tocilizumab, RO7283420, Diphenhydramine, Paracetamol/acetaminophen · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
RO7283420 Part BExperimental Group · 6 Interventions: Dasatinib, Dexamethasone, Tocilizumab, RO7283420, Diphenhydramine, Paracetamol/acetaminophen · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
RO7283420 Part AExperimental Group · 6 Interventions: Dasatinib, Dexamethasone, Tocilizumab, RO7283420, Diphenhydramine, Paracetamol/acetaminophen · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
RO7283420 Part CExperimental Group · 6 Interventions: Dasatinib, Dexamethasone, Tocilizumab, RO7283420, Diphenhydramine, Paracetamol/acetaminophen · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved
Dexamethasone
FDA approved
Tocilizumab
FDA approved
Diphenhydramine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to approximately 4 years

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,352 Previous Clinical Trials
1,093,788 Total Patients Enrolled
15 Trials studying Leukemia, Myeloid
1,364 Patients Enrolled for Leukemia, Myeloid
Clinical TrialsStudy DirectorHoffmann-La Roche
2,134 Previous Clinical Trials
901,282 Total Patients Enrolled
15 Trials studying Leukemia, Myeloid
1,033 Patients Enrolled for Leukemia, Myeloid

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have confirmed diagnosis of primary or secondary AML according to WHO classification 2016, with measurable disease.
You have a performance status of 0-2.
You are a male or female participant aged 18 years or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.