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

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7283420
RO7283420
Tocilizumab
Dasatinib
Dexamethasone
Paracetamol/acetaminophen
Diphenhydramine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • City of Hope
  • UC Davis Comprehensive Cancer Center
  • Washington University; Wash Uni. Sch. Of Med
  • The University of Texas MD Anderson Cancer Center
  • Peter MacCallum Cancer Centre; Medical Oncology
  • The Alfred
  • Princess Margaret Cancer Center
  • Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KATRecruiting
  • Institut Paoli Calmettes; Departement D' Onco-HematologieRecruiting
  • Hopital De Haut Leveque; Hematologie Clinique
  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
  • Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik IIIRecruiting
  • ASST PAPA GIOVANNI XXIII; Ematologia
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • Ospedale Santa Chiara; Unita Operativa Di Ematologia
  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol
  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital Univ. 12 de Octubre; Servicio de Hematologia
  • Hospital Universitario la Fe; Servicio de Hematologia
  • China Medical University Hospital; Oncology and HematologyRecruiting
  • National Cheng Kung University Hospital; OncologyRecruiting
  • National Taiwan Universtiy Hospital; Division of Hematology
  • Churchill HospitalRecruiting
  • Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A: Single Participant Dose Escalation

Part B: Multiple Participant Dose Escalation

Part C: Dose Expansion

Arm Description

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.

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.

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

Outcomes

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

Maximum Reduction (%) from Baseline in Blast Count in Peripheral Blood and/or Bone Marrow (Group I Dose Escalation Cohorts only)
Percentage of Participants who Achieve a Response
Defined by ELN 2017 recommendations, i.e., complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with absence of measurable residual disease (CRMRD-), and partial remission (PR).
Transfusion Independence
Event-free Survival (EFS)
Duration of Response (DoR)
Time to Hematological Relapse (Group II Only)
Early Mortality Rate
Progression-free Survival (PFS)
Number of MRD (Measurable Residual Disease) Negative Participants over time According to Local MRD Assessment
Area Under the Curve (AUC) of RO7283420
Maximum Concentration (Cmax) of RO7283420
Minimum Concentration (Cmin) of RO7283420
Clearance (Cl) of RO7283420
Volume (V) of RO7283420
Half-life (T1/2) of RO7283420
Incidence and Titer of Anti-drug Antibodies (ADA) against RO7283420

Full Information

First Posted
October 1, 2020
Last Updated
October 12, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04580121
Brief Title
A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed Description
The study will include AML participants with measurable disease, for whom standard-of-care (SOC) is not available. Two Groups of AML participants will be included in this study: Group I participants will have hematologic relapse/refractory disease defined as participants not in complete remission (CR) or complete remission with incomplete hematologic recovery (CRi). Group II participants will have molecular relapse/persistent disease (participants with a CR or CRi, and a positive MRD based on local multi-parameter flow cytometry (MFC) or molecular assessment). The study consists of three parts: Part A (single-participant dose escalation cohorts) - single participants from Group I will receive increment-based escalating doses until a Grade >=2 AE related to RO7283420 or a clear pharmacodynamic effect Part B (multiple-participant dose escalation cohorts) - multiple-participant cohorts of >=3 participants will be enrolled for dose escalation for Group I and Group II independently. Part C (dose expansion) - participants will receive the respective identified RP2D for that group. The treatment period for each participant will be up to 7 months with a maximum number of cycles depending on the dosing frequency the participant receives. 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. Additional 3, 5, or 9 cycles may be administered for the Q3W, Q2W, and QW dosing regimens, respectively, in case the participants have achieved at least partial remission (PR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Single Participant Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Multiple Participant Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Part C: Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive the respective RP2D for Group I and Group II.
Intervention Type
Drug
Intervention Name(s)
RO7283420
Intervention Description
RO7283420 will be administered to participants by intravenous (IV) infusion Q3W at a starting dose of 0.15mg. Starting dose levels (double step-up regimen, Q3W) for SC injections was the same as the highest dose levels that have been cleared in the IV double step-up cohorts at that timepoint. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, Q2W, or QW dosing regimens, respectively.
Intervention Type
Drug
Intervention Name(s)
RO7283420
Intervention Description
RO7283420 at RP2D will be administered by IV infusion or SC injection as per dosing schedule determined in Part B.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Actemra, RoActemra
Intervention Description
Tocilizumab will be administered as an IV infusion 8 mg/kg (for participants with a weight of 30 kg and above) and 12 mg/kg (for participants with a weight of less than 30 kg). Tocilizumab will be given as rescue medication.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Intervention Description
Dasatinib 100 mg film-coated tablets will be administered daily until symptom resolution (up to 100 mg twice daily [BID] for a maximum 3 days); orally. Dasatinib will be given as rescue medication.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
20 mg IV of dexamethasone will be administered as pre-medication at least 60 minutes prior to the all RO7283420 infusions or injections during cycle 1.
Intervention Type
Drug
Intervention Name(s)
Paracetamol/acetaminophen
Intervention Description
500 or 1000 mg of paracetamol/acetaminophen will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection.
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
25 mg or 50 mg of diphenhydramine will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
From baseline up to 9 months
Title
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame
From baseline up to 28 days
Title
Recommended Phase II Dose (RP2D)
Time Frame
From baseline up to 7 months
Secondary Outcome Measure Information:
Title
Maximum Reduction (%) from Baseline in Blast Count in Peripheral Blood and/or Bone Marrow (Group I Dose Escalation Cohorts only)
Time Frame
From baseline up to 7 months
Title
Percentage of Participants who Achieve a Response
Description
Defined by ELN 2017 recommendations, i.e., complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with absence of measurable residual disease (CRMRD-), and partial remission (PR).
Time Frame
From baseline up to approximately 4 years
Title
Transfusion Independence
Time Frame
From baseline up to 7 months
Title
Event-free Survival (EFS)
Time Frame
From baseline to the time to progression, relapse, death from any cause, or start of a new treatment (up to approximately 4 years)
Title
Duration of Response (DoR)
Time Frame
From first occurrence of a documented response until the time of documented relapse, disease progression or death from any cause, whichever occurs first (up to approximately 4 years)
Title
Time to Hematological Relapse (Group II Only)
Time Frame
From baseline until the time of documented hematological relapse
Title
Early Mortality Rate
Time Frame
From baseline to Day 30, and to Day 60
Title
Progression-free Survival (PFS)
Time Frame
From Cycle 1 Day 1 to the first occurrence of documented disease progression, or death from any cause, whichever occurs first (up to approximately 4 years)
Title
Number of MRD (Measurable Residual Disease) Negative Participants over time According to Local MRD Assessment
Time Frame
From baseline up to 7 months
Title
Area Under the Curve (AUC) of RO7283420
Time Frame
Day 1, 2, 3, 8, 15 of Cycle 1 (each cycle is 21 days); Day 1, 2, 3, 8 of Cycle 2 only in case of triple step-up dosing; Day 1 of Cycle 2-9 (Q3W), 2-14 (Q2W), 2-27 (QW); end of treatment visit.
Title
Maximum Concentration (Cmax) of RO7283420
Time Frame
Day 1, 2, 3, 8, 15 of Cycle 1 (each cycle is 21 days); Day 1, 2, 3, 8 of Cycle 2 only in case of triple step-up dosing; Day 1 of Cycle 2-9 (Q3W), 2-14 (Q2W), 2-27 (QW); end of treatment visit.
Title
Minimum Concentration (Cmin) of RO7283420
Time Frame
Day 1, 2, 3, 8, 15 of Cycle 1 (each cycle is 21 days); Day 1, 2, 3, 8 of Cycle 2 only in case of triple step-up dosing; Day 1 of Cycle 2-9 (Q3W), 2-14 (Q2W), 2-27 (QW); end of treatment visit.
Title
Clearance (Cl) of RO7283420
Time Frame
Day 1, 2, 3, 8, 15 of Cycle 1 (each cycle is 21 days); Day 1, 2, 3, 8 of Cycle 2 only in case of triple step-up dosing; Day 1 of Cycle 2-9 (Q3W), 2-14 (Q2W), 2-27 (QW); end of treatment visit.
Title
Volume (V) of RO7283420
Time Frame
Day 1, 2, 3, 8, 15 of Cycle 1 (each cycle is 21 days); Day 1, 2, 3, 8 of Cycle 2 only in case of triple step-up dosing; Day 1 of Cycle 2-9 (Q3W), 2-14 (Q2W), 2-27 (QW); end of treatment visit.
Title
Half-life (T1/2) of RO7283420
Time Frame
Day 1, 2, 3, 8, 15 of Cycle 1 (each cycle is 21 days); Day 1, 2, 3, 8 of Cycle 2 only in case of triple step-up dosing; Day 1 of Cycle 2-9 (Q3W), 2-14 (Q2W), 2-27 (QW); end of treatment visit.
Title
Incidence and Titer of Anti-drug Antibodies (ADA) against RO7283420
Time Frame
Day 1, 8, 15 of Cycle 1 (each cycle is 21 days); Day 1 and 8 of Cycle 2, Day 1 of Cycle 3-9 (Q3W), 3-14 (Q2W), 3-27 (QW); at end of treatment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WP42004 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Withdrawn
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Completed
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Individual Site Status
Completed
Facility Name
Peter MacCallum Cancer Centre; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Completed
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Individual Site Status
Completed
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Completed
Facility Name
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Institut Paoli Calmettes; Departement D' Onco-Hematologie
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital De Haut Leveque; Hematologie Clinique
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
ASST PAPA GIOVANNI XXIII; Ematologia
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Completed
Facility Name
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Completed
Facility Name
Ospedale Santa Chiara; Unita Operativa Di Ematologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Individual Site Status
Completed
Facility Name
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Univ. 12 de Octubre; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario la Fe; Servicio de Hematologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Completed
Facility Name
China Medical University Hospital; Oncology and Hematology
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital; Oncology
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan Universtiy Hospital; Division of Hematology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Completed
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Citations:
PubMed Identifier
34280257
Citation
Augsberger C, Hanel G, Xu W, Pulko V, Hanisch LJ, Augustin A, Challier J, Hunt K, Vick B, Rovatti PE, Krupka C, Rothe M, Schonle A, Sam J, Lezan E, Ducret A, Ortiz-Franyuti D, Walz AC, Benz J, Bujotzek A, Lichtenegger FS, Gassner C, Carpy A, Lyamichev V, Patel J, Konstandin N, Tunger A, Schmitz M, von Bergwelt-Baildon M, Spiekermann K, Vago L, Jeremias I, Marrer-Berger E, Umana P, Klein C, Subklewe M. Targeting intracellular WT1 in AML with a novel RMF-peptide-MHC-specific T-cell bispecific antibody. Blood. 2021 Dec 23;138(25):2655-2669. doi: 10.1182/blood.2020010477. Erratum In: Blood. 2022 Mar 31;139(13):2086-2087.
Results Reference
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A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.

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