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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06630806




Registration number
NCT06630806
Ethics application status
Date submitted
3/10/2024
Date registered
8/10/2024

Titles & IDs
Public title
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
Scientific title
A First-in-human, Open-label, Phase 1 Study to Evaluate the Safety, Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SAR446523, an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
U1111-1301-4016
Secondary ID [2] 0 0
TED18162
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma Cell Myeloma Refractory 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 - SAR446523

Experimental: Part A (Dose escalation) - Participants will receive SAR446523

Experimental: Part B Dose-1 (Dose optimization) - Participants will receive SAR446523 Dose-1

Experimental: Part B Dose-2 (Dose optimization) - Participants will receive SAR446523 Dose-2


Treatment: Drugs: SAR446523
Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A)
Timepoint [1] 0 0
Cycle 1 (28 days)
Primary outcome [2] 0 0
Overall response rate (ORR) - Dose optimization (Part B)
Timepoint [2] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [1] 0 0
Number of participants with treatment emergent adverse events (TEAEs), injection related reactions (IRRs), injection site reactions (ISRs), serious adverse events (SAEs), adverse event of special interests (AESIs)
Timepoint [1] 0 0
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Secondary outcome [2] 0 0
Change from baseline in laboratory abnormalities
Timepoint [2] 0 0
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Secondary outcome [3] 0 0
ORR- Dose escalation (Part A)
Timepoint [3] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [4] 0 0
VGPR or better rate
Timepoint [4] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [5] 0 0
Clinical benefit rate (CBR)
Timepoint [5] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [6] 0 0
Duration of response (DoR)
Timepoint [6] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [7] 0 0
Time to response (TTR)
Timepoint [7] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [8] 0 0
Progression free survival (PFS)
Timepoint [8] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [9] 0 0
Minimal residual disease (MRD) status negativity
Timepoint [9] 0 0
24 months after the Last Participant In (LPI)
Secondary outcome [10] 0 0
Number of participants with symptomatic AEs -Part B
Timepoint [10] 0 0
From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Secondary outcome [11] 0 0
Change from baseline in overall side effect bother as measured by the Functional Assessment of Cancer Therapy item 5 (FACT-GP5)- Part B
Timepoint [11] 0 0
From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Secondary outcome [12] 0 0
Maximum observed concentration (Cmax)
Timepoint [12] 0 0
Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
Secondary outcome [13] 0 0
First time to reach Cmax (tmax)
Timepoint [13] 0 0
Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
Secondary outcome [14] 0 0
Area under the concentration versus time curve calculated from 0 to 168 hours (AUC0-168h)
Timepoint [14] 0 0
Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
Secondary outcome [15] 0 0
Proportion of participants with presence of anti-drug antibody (ADA) against SAR446523.
Timepoint [15] 0 0
From Cycle 1 Day 1 to 90 days after the date of the last study treatment administration i.e., approximately 5 years

Eligibility
Key inclusion criteria
* Participants with a documented diagnosis of multiple myeloma (MM) with measurable disease.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Dose escalation (Part A) -Participants must have received at least 3 prior lines of antimyeloma therapy which must include a second or third generation immunomodulator, proteosome inhibitor (PI), and anti CD38 monoclonal antibody (mAb) administered with the same or different line.

AND

* Must be either relapsed or refractory to the above therapies, or are intolerant to them, based up on the Investigator's judgment.
* Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group 5, member d (GPRC5D) therapy and anti B-cell maturation antigen (BCMA) therapy is allowed.

Dose optimization (Part B)

* Participants must have received at least 3 prior lines of antimyeloma therapy which must include a second or third generation immunomodulator, PI, anti-CD38 mAb, and anti-B Cell Maturation Antigen (anti-BCMA) agent. AND
* Must be either relapsed or refractory to the above therapies, or are intolerant to them, based up on the Investigator's judgment.
* Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Participants are excluded from the study if any of the following criteria apply: Eastern cooperative oncology group performance status (ECOG PS) of 2 or greater.

* Primary systemic and localized amyloid light chain (AL) amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia.
* Systemic antimyeloma treatment within 14 days before the first study treatment administration.
* Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal antibody with antibody-dependent cellular cytotoxicity as primary mechanism of action) within 90 days of the first study treatment administration.
* Inadequate organ and marrow function.
* Participants with significant concomitant illness.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

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
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
30/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/05/2029
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
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 patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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/NCT06630806