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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04557150




Registration number
NCT04557150
Ethics application status
Date submitted
17/09/2020
Date registered
21/09/2020
Date last updated
5/05/2021

Titles & IDs
Public title
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
Scientific title
An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2020-002012-46
Secondary ID [2] 0 0
BP42233
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - RO7425781

Experimental: Part I: Dose Escalation - Participants will receive RO7425781 as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.

Experimental: Part II: Dose Expansion - Dose Expansion cohorts with IV and/or SC administration will be initiated at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) determined from Part I: Dose Escalation.


Treatment: Drugs: RO7425781
RO7425781 will be administered via IV/SC administration. The MTD/RP2D determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. RO7425781 will be administered as per the dosing schedule defined in Part I.

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)
Timepoint [1] 0 0
Up to 69 weeks
Primary outcome [2] 0 0
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Up to 69 weeks
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 69 weeks
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 69 weeks
Secondary outcome [3] 0 0
Progression-Free Survival (PFS)
Timepoint [3] 0 0
Up to 69 weeks
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to 69 weeks
Secondary outcome [5] 0 0
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7425781
Timepoint [5] 0 0
Up to 69 weeks
Secondary outcome [6] 0 0
Maximum concentration (Cmax) of RO7425781
Timepoint [6] 0 0
Up to 69 weeks
Secondary outcome [7] 0 0
Time of Maximum concentration (Tmax) of RO7425781
Timepoint [7] 0 0
Up to 69 weeks
Secondary outcome [8] 0 0
Minimum concentration (Cmin) of RO7425781
Timepoint [8] 0 0
Up to 69 weeks
Secondary outcome [9] 0 0
SC Bioavailability (F) of RO7425781
Timepoint [9] 0 0
Up to 69 weeks
Secondary outcome [10] 0 0
Apparent Clearance (CL/F) of RO7425781
Timepoint [10] 0 0
Up to 69 weeks
Secondary outcome [11] 0 0
Volume of distribution at steady state (Vss) of RO7425781 (IV only)
Timepoint [11] 0 0
Up to 69 weeks
Secondary outcome [12] 0 0
Area under the curve (AUC) at various time intervals of RO7425781
Timepoint [12] 0 0
Up to 69 weeks

Eligibility
Key inclusion criteria
- Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.

- Dose Escalation Phase: Participants with r/r MM who have previously received therapy
with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant
to or have no other option for standard-of-care treatment according to the
Investigator.

- Dose Expansion Phase: Participants with r/r MM who have received at least three prior
treatments and are refractory to an IMiD, a PI, and a CD38-targeted therapy.

- Life expectancy of at least 12 weeks.

- Agreement to provide protocol-specific biopsy material.

- AEs from prior anti-cancer therapy resolved to Grade =<1.

- Measurable disease.

- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse), use contraceptive measures and refrain from
donating eggs.

- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse), use contraceptive measures and refrain from donating sperm.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to comply with protocol-mandated hospitalization and activities
restrictions.

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
3 months after the last dose of study drug.

- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate
within 2 weeks before first RO7425781 administration.

- Prior treatment with systemic immunotherapeutic agents within 2 weeks before first
RO7425781 administration.

- Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.

- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other
anti-cancer agent (investigational or otherwise) within 2 weeks except for alkylating
agents (e.g., melphalan) within 28 days, prior to first RO7425781 administration.
Limited field palliative radiotherapy for bone pain or for soft tissue lesions is
allowed.

- Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to
first RO7425781 administration and/or signs of chronic graft versus host disease or
ongoing immunosuppressive medication.

- Prior solid organ transplantation.

- Any medical condition or abnormality in clinical laboratory tests that, in the
Investigator's or Medical Monitor's judgment, precludes the participant's safe
participation in and completion of the study, or which could affect compliance with
the protocol or interpretation of results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Other
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)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Denmark
State/province [4] 0 0
København Ø
Country [5] 0 0
France
State/province [5] 0 0
Lille
Country [6] 0 0
France
State/province [6] 0 0
Nantes
Country [7] 0 0
France
State/province [7] 0 0
Pessac
Country [8] 0 0
Italy
State/province [8] 0 0
Campania
Country [9] 0 0
Italy
State/province [9] 0 0
Lombardia
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Spain
State/province [11] 0 0
Cantabria
Country [12] 0 0
Spain
State/province [12] 0 0
Navarra
Country [13] 0 0
Spain
State/province [13] 0 0
Salamanca
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Leeds
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy,
dose-escalation and dose expansion study. RO7425781 will be administered to participants with
r/r MM for whom no standard-of-care treatment exists or who are intolerant to those
established therapies. The study consists of two parts: dose-escalation of RO7425781 (Part 1)
and a randomized dose expansion of RO7425781 (Part 2).
Trial website
https://clinicaltrials.gov/show/NCT04557150
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: BP42233 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-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04557150