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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04434469




Registration number
NCT04434469
Ethics application status
Date submitted
12/06/2020
Date registered
16/06/2020

Titles & IDs
Public title
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
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
Secondary ID [1] 0 0
GO41582
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory Multiple Myeloma 0 0
Relapsed Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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 - No 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.

Experimental: Phase I Expansion Stage: RO7297089 - No 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.


Treatment: Drugs: RO7297089
RO7297089 will be given via intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Baseline up to 1 year 7 months
Secondary outcome [1] 0 0
Time to Maximum Concentration Observed (Tmax) of RO7297089
Timepoint [1] 0 0
Cycle 1 Day 1
Secondary outcome [2] 0 0
Area Under the Curve (AUC) of RO7297089
Timepoint [2] 0 0
Cycle 1 Day 1
Secondary outcome [3] 0 0
Maximum Concentration Observed (Cmax) of RO7297089
Timepoint [3] 0 0
Cycle 1 Day 1, Cycle 2 Day 8
Secondary outcome [4] 0 0
Minimum Concentration Observed (Cmin) of RO7297089
Timepoint [4] 0 0
Cycle 1 Day 1, Cycle 2 Day 8
Secondary outcome [5] 0 0
Half-life (t1/2) of RO7297089
Timepoint [5] 0 0
Cycle 1 Day 1
Secondary outcome [6] 0 0
Objective Response Rate (ORR)
Timepoint [6] 0 0
Baseline up to approximately 19 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/02/2022
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research - Liverpool
Recruitment hospital [3] 0 0
Royal Adelaide Hospital; Haematology Clinical Trials - Adelaide
Recruitment hospital [4] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Peter Mac Callum Cancer Center - East Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Denmark
State/province [3] 0 0
København Ø
Country [4] 0 0
Denmark
State/province [4] 0 0
Vejle
Country [5] 0 0
Norway
State/province [5] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04434469