A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
1 other identifier
interventional
27
4 countries
10
Brief Summary
This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2020
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2022
CompletedResults Posted
Study results publicly available
July 3, 2024
CompletedJuly 3, 2024
June 1, 2024
1.6 years
June 12, 2020
February 23, 2023
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
Adverse event severity graded according to NCI CTCAE v5.0
Baseline up to 1 year 7 months
Secondary Outcomes (6)
Time to Maximum Concentration Observed (Tmax) of RO7297089
Cycle 1 Day 1
Area Under the Curve (AUC) of RO7297089
Cycle 1 Day 1
Maximum Concentration Observed (Cmax) of RO7297089
Cycle 1 Day 1, Cycle 2 Day 8
Minimum Concentration Observed (Cmin) of RO7297089
Cycle 1 Day 1, Cycle 2 Day 8
Half-life (t1/2) of RO7297089
Cycle 1 Day 1
- +1 more secondary outcomes
Study Arms (4)
Arm A Flat Dose Escalation: RO7297089
EXPERIMENTALParticipants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Arm B Split Dose Escalation: RO7297089
EXPERIMENTALParticipants in Arm B will receive the first target dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose will be administered at subsequent study drug administration visits.
Arm C Step Dose Escalation: RO7297089
EXPERIMENTALNo participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
Phase I Expansion Stage: RO7297089
EXPERIMENTALNo participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
Interventions
RO7297089 will be given via intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
- Measurable disease
You may not qualify if:
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first RO7297089 infusion
- Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
- Prior treatment with CAR-T therapy within 90 days before first study drug administration
- Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first RO7297089 infusion
- Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
- Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
- Primary or secondary plasma cell leukemia
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
- Significant cardiovascular disease
- Current CNS involvement by MM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (10)
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
Liverpool, New South Wales, 2170, Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide, South Australia, 5000, Australia
St. Vincent's Hospital Melbourne
Fitzroy, South Australia, 3065, Australia
Peter Mac Callum Cancer Center
East Melbourne, Victoria, 3002, Australia
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Rigshospitalet
København Ø, 2100, Denmark
Vejle Sygehus; Onkologisk Afdeling
Vejle, 7100, Denmark
Oslo Universitetssykehus HF; Ullevål sykehus
Oslo, 0450, Norway
Related Publications (1)
Plesner T, Harrison SJ, Quach H, Lee C, Bryant A, Vangsted A, Estell J, Delforge M, Offner F, Twomey P, Choeurng V, Li J, Hendricks R, Ruppert SM, Sumiyoshi T, Miller K, Cho E, Schjesvold F. Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma. Clin Hematol Int. 2023 Mar;5(1):43-51. doi: 10.1007/s44228-022-00023-5. Epub 2023 Jan 19.
PMID: 36656461DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genetech
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 16, 2020
Study Start
July 8, 2020
Primary Completion
February 23, 2022
Study Completion
February 23, 2022
Last Updated
July 3, 2024
Results First Posted
July 3, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
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/members/ourmembers/). 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)