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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05646836




Registration number
NCT05646836
Ethics application status
Date submitted
2/12/2022
Date registered
12/12/2022

Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
A Phase Ib, Open-label, Multicenter Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Patients With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
2022-001204-18
Secondary ID [2] 0 0
GO43980
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 - Cevostamab
Treatment: Drugs - XmAb24306
Treatment: Drugs - Tocilizumab

Experimental: Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab - Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled.

Experimental: Arm B: Single-Agent Cevostamab Expansion - Participants will receive cevostamab alone.


Treatment: Drugs: Cevostamab
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Treatment: Drugs: XmAb24306
XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Treatment: Drugs: Tocilizumab
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
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 approximately 3 years
Secondary outcome [1] 0 0
Serum Concentration of XmAb24306
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Serum Concentration of Cevostamab
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Rate of Complete Response (CR)/ Stringent Complete Response (sCR)
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Rate of Very Good Partial Response (VGPR)
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab
Timepoint [6] 0 0
Up to approximately 3 years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 12 weeks
* Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody.
* Documented evidence of progressive disease on or after the last prior therapy, or participants who were intolerant to the last prior therapy.
* Measurable disease, as defined by the protocol
* Participants agree to follow contraception or abstinence requirements as defined in the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any anti-cancer therapy within 3 weeks prior to initiation of study treatment with exception defined by the protocol
* Participants with autologous stem cell transplantation (SCT) within 100 days prior to first dose of study treatment
* Participants with prior allogeneic SCT or solid organ transplantation
* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
* Active or history of autoimmune disease
* Participants with current or history of Central Nervous System (CNS) disease, or current CNS involvement by Multiple Myeloma (MM)
* Significant cardiovascular disease
* Participants with known clinically significant liver disease
* Symptomatic active pulmonary disease requiring supplemental oxygen
* Known active infection requiring intravenous anti-microbial therapy within 14 days prior to first study drug administration
* Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment
* Other protocol defined inclusion/exclusion criteria may apply

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
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
21/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/01/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Vejle
Country [2] 0 0
Greece
State/province [2] 0 0
Athens
Country [3] 0 0
Israel
State/province [3] 0 0
Petach Tikva
Country [4] 0 0
Israel
State/province [4] 0 0
Tel Aviv-Yafo
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
Norway
State/province [6] 0 0
Oslo
Country [7] 0 0
Spain
State/province [7] 0 0
Navarra
Country [8] 0 0
Spain
State/province [8] 0 0
Valencia

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
Reference Study ID Number: GO43980 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
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/ourmember/roche/). 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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05646836