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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04434469
Ethics application status
Date submitted
12/06/2020
Date registered
16/06/2020
Date last updated
30/10/2020

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: Phase I Dose-Escalation Stage: RO7297089 - Cohorts of at least 3 participants each will be treated with escalating doses of RO7297089 to determine the MTD or maximum administered dose (MAD)

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

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) - Adverse event severity will be graded according to NCI CTCAE v5.0
Timepoint [1] 0 0
Baseline up to approximately 3 years
Secondary outcome [1] 0 0
Serum Concentration of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [1] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [2] 0 0
Area under the Curve (AUC) of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [2] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [3] 0 0
Maximum Concentration Observed (Cmax) of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [3] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [4] 0 0
Time to Maximum Concentration Observed (tmax) of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [4] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [5] 0 0
Minimum Concentration Observed (Cmin) of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [5] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [6] 0 0
Volume of Distribution at Steady State of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [6] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [7] 0 0
Half-life of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [7] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [8] 0 0
Total clearance of RO7297089 - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [8] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)
Secondary outcome [9] 0 0
Objective Response Rate (ORR) - 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
Timepoint [9] 0 0
Baseline up to approximately 3 years
Secondary outcome [10] 0 0
Duration Of Response (DOR) - 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
Timepoint [10] 0 0
Baseline up to approximately 3 years
Secondary outcome [11] 0 0
Prevalence Of Anti-Drug Antibodies (ADAs) - Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Timepoint [11] 0 0
Baseline up to approximately 3 years (detailed time frame provided in description)

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
Gender
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 radiotherapy, 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Peter Mac Callum Cancer Center - East Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
København Ø
Country [2] 0 0
Denmark
State/province [2] 0 0
Vejle
Country [3] 0 0
Norway
State/province [3] 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/show/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
Reference Study ID Number: GO41582 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global.rochegenentechtrials@roche.com
Contact person for scientific queries

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