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NCT04580121COMPLETEDanonymous

An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia

Sponsor

Source record

Hoffmann-La Roche

Phase

Source record

Phase 1

Modality

AI-normalized

small molecule

Target

AI-normalized

HLA-A*02

Indication / condition

AI-normalized

Acute Myeloid Leukemia

Intervention

Source record

RO7283420, RO7283420, Tocilizumab, Dasatinib, Dexamethasone, Paracetamol/acetaminophen, Diphenhydramine

Source & freshness

Source record

NCT ID

NCT04580121

Original source

ClinicalTrials.gov

Source last updated

Jun 03, 2024

Ingested at

Jun 16, 2026

Internal sync

Jun 16, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT04580121

Title

An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia

Sponsor

Hoffmann-La Roche

Status

COMPLETED

Phase

Phase 1

Condition raw

Acute Myeloid Leukemia

Condition normalized

Acute Myeloid Leukemia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

HLA-A*02

Target normalized

HLA-A*02

Interventions

RO7283420, RO7283420, Tocilizumab, Dasatinib, Dexamethasone, Paracetamol/acetaminophen, Diphenhydramine

Public preview

Source record

RO7283420, developed by Hoffmann-La Roche, is currently in Phase 1 clinical trials targeting hematologic and molecular relapsed/refractory Acute Myeloid Leukemia (AML). The asset aims to address a significant unmet need in a market characterized by limited treatment options for patients who have exhausted standard-of-care therapies. The competitive landscape includes existing therapies such as targeted agents and immunotherapies, but RO7283420's unique mechanism as a bispecific antibody targeting WT1 may provide a differentiated therapeutic profile. Successful outcomes in this trial could position Roche favorably for subsequent Phase 2 studies and potential market entry, enhancing its portfolio in oncology and solidifying its presence in the AML treatment space.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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