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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04434469
Registration number
NCT04434469
Ethics application status
Date submitted
12/06/2020
Date registered
16/06/2020
Date last updated
2/06/2022
Titles & IDs
Public title
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
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Scientific title
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
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Secondary ID [1]
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GO41582
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Refractory Multiple Myeloma
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Relapsed Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RO7297089
Experimental: Arm A Flat Dose Escalation: RO7297089 - Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Experimental: Arm B Split Dose Escalation: RO7297089 - Participants 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.
Experimental: Arm C Step Dose Escalation: RO7297089 - Participants in Arm C will receive the first cycle of RO7297089 as a single-step dose escalation. The Cycle 1 Day 1 dose will be lower than the target dose. The full target dose will be administered at subsequent study drug administration visits.
Experimental: Phase I Expansion Stage: RO7297089 - After dose escalation has been completed, approximately 30 patients will be enrolled in the expansion stage. Participants will receive RO7297089 at the recommended phase 2 dose (at or below the maximum tolerated dose).
Treatment: Drugs: RO7297089
RO7297089 will be given via intravenous (IV) infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants with Adverse Events (AEs), including Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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Adverse event severity will be graded according to NCI CTCAE v5.0
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Timepoint [1]
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Baseline up to approximately 3 years
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Secondary outcome [1]
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Serum Concentration of RO7297089
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Assessment method [1]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [1]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [2]
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Area under the Curve (AUC) of RO7297089
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Assessment method [2]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [2]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [3]
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Maximum Concentration Observed (Cmax) of RO7297089
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Assessment method [3]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [3]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [4]
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Time to Maximum Concentration Observed (tmax) of RO7297089
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Assessment method [4]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [4]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [5]
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Minimum Concentration Observed (Cmin) of RO7297089
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Assessment method [5]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [5]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [6]
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Volume of Distribution at Steady State of RO7297089
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Assessment method [6]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [6]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [7]
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Half-life of RO7297089
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Assessment method [7]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [7]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [8]
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Total clearance of RO7297089
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Assessment method [8]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [8]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Secondary outcome [9]
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Objective Response Rate (ORR)
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Assessment method [9]
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ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria
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Timepoint [9]
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Baseline up to approximately 3 years
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Secondary outcome [10]
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Duration Of Response (DOR)
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Assessment method [10]
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DOR is defined as the time from the first occurrence of a documented Objective Response to Disease Progression or death from any cause (whichever occurs first), as determined by the Investigator according to IMWG Uniform Response Criteria
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Timepoint [10]
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Baseline up to approximately 3 years
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Secondary outcome [11]
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Prevalence Of Anti-Drug Antibodies (ADAs)
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Assessment method [11]
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Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
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Timepoint [11]
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Baseline up to approximately 3 years (detailed time frame provided in description)
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Eligibility
Key inclusion criteria
Inclusion Criteria
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/02/2022
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research - Liverpool
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Recruitment hospital [3]
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Royal Adelaide Hospital; Haematology Clinical Trials - Adelaide
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Recruitment hospital [4]
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St. Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [5]
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Peter Mac Callum Cancer Center - East Melbourne
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Gent
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Country [2]
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Belgium
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State/province [2]
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Leuven
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Country [3]
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Denmark
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State/province [3]
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København Ø
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Country [4]
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Denmark
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State/province [4]
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Vejle
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Country [5]
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Norway
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State/province [5]
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Oslo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genentech, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04434469
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04434469
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