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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
Date last updated
3/07/2024

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
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 website
https://clinicaltrials.gov/study/NCT04434469
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04434469