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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1301-4016 | Other Identifier | WHO ICTRP | |
| 2024-511667-28 | Registry Identifier | CTIS |
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This is a first-in-human study of SAR446523 conducted in patients with RRMM.
The study consists of two parts:
Dose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.
Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.
The study will be considered ongoing until the last participant last visit has occurred. Participants will be allowed to continue therapy until disease progression, unacceptable AEs, participant or Investigator's request to discontinue treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (Dose escalation) | Experimental | Participants will receive SAR446523 |
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| Part B Dose-1 (Dose optimization) | Experimental | Participants will receive SAR446523 Dose-1 |
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| Part B Dose-2 (Dose optimization) | Experimental | Participants will receive SAR446523 Dose-2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR446523 | Drug | Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A) | The incidence of DLTs will be evaluated using NCI CTCAE version 5.0 criteria. | Cycle 1 (28 days) |
| Overall response rate (ORR) - Dose optimization (Part B) | ORR is defined as the proportion of participants with sCR, CR, VGPR, and PR assessed as per Investigator according to the 2016 IMWG response criteria. | 24 months after the Last Participant In (LPI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Measured as per NCI CTCAE v 5.0 | From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years |
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Inclusion Criteria:
Dose escalation (Part A)
Dose optimization (Part B)
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.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona - Phoenix- Site Number : 8400005 | Recruiting | Phoenix | Arizona | 85054 | United States | |
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| Label | URL |
|---|---|
| TED18162 Plain Language Results Summary | View source |
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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
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Study is non-randomized for part A but randomized for part B. Study drug will be assigned in sequential manner in Part A but parallel assignment in Part B.
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| Change from baseline in laboratory abnormalities | Measured as per NCI CTCAE v 5.0. | From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years |
| ORR- Dose escalation (Part A) | ORR defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed as per Investigator according to the 2016 International Myeloma Working Group (IMWG) response criteria. | 24 months after the Last Participant In (LPI) |
| VGPR or better rate | VGPR or better rate defined as the proportion of participants with sCR, CR, and VGPR assessed as per Investigator according to the 2016 IMWG response criteria. | 24 months after the Last Participant In (LPI) |
| Clinical benefit rate (CBR) | CBR defined as the rate of participants with confirmed sCR, CR, VGPR, or PR at any time or minimal response (MR) of at least 6 months from the first IMP administration determined per 2016 IMWG response criteria. | 24 months after the Last Participant In (LPI) |
| Duration of response (DoR) | DoR defined as the time from the date of the first response (PR or better) to the date of first documentation of progressive disease (PD) as defined in the 2016 IMWG response criteria, or date of death, whichever occurs first. | 24 months after the Last Participant In (LPI) |
| Time to response (TTR) | TTR defined as the time from the first administration of study IMP to the date of first response (PR or better) that is subsequently confirmed. | 24 months after the Last Participant In (LPI) |
| Progression free survival (PFS) | PFS defined as the time interval from the date of first administration of study IMP to the date of first documentation of PD per 2016 IMWG criteria assessed by study Investigator, or date of death from any cause, whichever comes first. | 24 months after the Last Participant In (LPI) |
| Minimal residual disease (MRD) status negativity | MRD status negative by nextgeneration sequencing (NGS) in bone marrow of participants with a response of CR (or VGPR in case of suspected interference). | 24 months after the Last Participant In (LPI) |
| Number of participants with symptomatic AEs -Part B | The incidence and evaluation of symptomatic AEs from participants' perspective will be measured by using specific items from National Cancer Institute (NCI) patient-reported outcome (PRO) common terminology criteria for adverse events (CTCAE) library. | From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years |
| Change from baseline in overall side effect bother as measured by the Functional Assessment of Cancer Therapy item 5 (FACT-GP5)- Part B | The FACT GP5 is an assessment focused on the overall side effect impact to inform the tolerability of a treatment. The FACT GP5 ("I am bothered by side effects of treatment") responses are given on a 5 point Likert type scale recalling the past 7 days. Higher scores indicate a higher degree of side effect bother. | From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years |
| Maximum observed concentration (Cmax) | To characterize the pharmacokinetics (PK) of SAR446523. | Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days) |
| First time to reach Cmax (tmax) | To characterize the PK of SAR446523. | Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days) |
| Area under the concentration versus time curve calculated from 0 to 168 hours (AUC0-168h) | To characterize the PK of SAR446523. | Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days) |
| Proportion of participants with presence of anti-drug antibody (ADA) against SAR446523. | To evaluate potential immunogenicity. | From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years |
| Mayo Clinic in Florida- Site Number : 8400003 |
| Recruiting |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400004 | Recruiting | Rochester | Minnesota | 55905 | United States |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001 | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Thomas Jefferson University Hospital- Site Number : 8400002 | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Investigational Site Number : 0360001 | Recruiting | Wollongong | New South Wales | 2500 | Australia |
| Investigational Site Number : 0360002 | Recruiting | Melbourne | Victoria | 3065 | Australia |
| Investigational Site Number : 1240005 | Recruiting | Vancouver | British Columbia | V5Z 1L3 | Canada |
| Investigational Site Number : 1240001 | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Investigational Site Number : 1240002 | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Investigational Site Number : 2500002 | Recruiting | Lille | 59037 | France |
| Investigational Site Number : 2500001 | Recruiting | Nantes | 44093 | France |
| Investigational Site Number : 3760001 | Recruiting | Tel Aviv | Malopolskie | 6423906 | Israel |
| Investigational Site Number : 3760004 | Recruiting | Haifa | 3109601 | Israel |
| Investigational Site Number : 3760002 | Recruiting | Jerusalem | 9112001 | Israel |
| Investigational Site Number : 3800002 | Recruiting | Torette | Ancona | 60020 | Italy |
| Investigational Site Number : 3800001 | Recruiting | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number : 7240002 | Recruiting | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number : 7240001 | Recruiting | Madrid | 28040 | Spain |