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

Cancer
Leukemia
Acute Myeloid Leukemia

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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 1

Study Identifier NCT04580121, WP42004, 2020-000216-30

Condition Acute Myeloid Leukemia

Official 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

Study Summary

This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

With confirmed diagnosis of primary or secondary AML according to WHO classification 2016, with measurable disease. Eligible participants need to have received standard-of-care (SOC) and have no other SOC options available Participants who are not willing to receive SOC will be not eligible. Two groups of participants (Group I - hematologic relapsed/refractory and Group II - molecular relapsed/refractory) will be included
Participants who have received hematopoietic stem cell transplant (HSCT) must have the HSCT performed ≥ 90 days prior to the first dose of RO7283420 on Cycle 1 Day 1, having demonstrated hematological engraftment and do not have an active Graft versus Host Disease, not requiring immunosuppressive treatment (including but not limited to cyclosporine, tacrolimus, sirolimus, and mycophenolate), which must be stopped at least 28 days prior to the first dose of RO7283420 on Cycle 1 Day 1
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Peripheral blast counts =< 20,000/mm3 on Cycle 1 Day 1 prior to the first dosing
Confirmed genotype of HLA-A*02
Adequate renal (a creatinine clearance of >=50 mL/min as calculated according to the Cockroft-Gault formula) and adequate liver test results
Male or female participants agree to use contraception and the abstinence requirements to prevent exposure of an embryo to the study treatment

Exclusion Criteria

Acute promyelocytic leukemia (APL)
Core Binding Factor (CBF)-AML Note: participants with r/r CBF-AML after at least 2 salvage attempts can be enrolled into the study
Group II only: participants with normal karyotype and a favorable molecular profile according to ELN guideline 2017
Participants with active bacterial, fungal or viral infection considered by the Investigator to be clinically uncontrolled or of unacceptable risk upon the induction of neutropenia (i.e. participants who are or should be on antimicrobial agents for the treatment of active infection)
Grade >= 2 glomerular proteinuria at screening or on Cycle 1 Day 1 prior to the first dosing.
Another primary malignancy (other than AML) that requires active therapy. Adjuvant hormonal therapy is allowed
Clinical evidence or history of central nervous system (CNS) leukemia
Presence of extramedullary disease at screening
Current or past history of CNS disease, such as stroke, CNS inflammation, epilepsy, CNS vasculitis, or neurodegenerative disease
Participants who have a history of clinically significant liver disease, including liver cirrhosis (e.g. Child-Pugh class B and C) or participants who have a history of active or chronic infectious hepatitis unless serology demonstrates clearance of infection
Participants who might refuse to receive blood products and/or have known hypersensitivity to any of the components of RO7283420, tocilizumab, or dasatinib

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS WP42004 Final Results July 2024 English (PDF, 0.4 MB)

LPS WP42004 Final Results July 2024 Denmark Danish (PDF, 0.4 MB)

LPS WP42004 Final Results July 2024 Italy Italian (PDF, 0.6 MB)

LPS WP42004 Final Results July 2024 Spain Spanish (PDF, 0.3 MB)

LPS WP42004 Final Results July 2024 Germany German (PDF, 0.7 MB)

LPS WP42004 Final Results July 2024 France French (PDF, 0.2 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com