A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Sanofi
Study ID
NCT06630806
Phase
PHASE1
Status
Recruiting
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Conditions

  • Plasma Cell Myeloma Refractory

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAR446523 — DRUG
    Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)

Study Details

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.

Key Dates

Start date
Oct 30, 2024
Status verified
Mar 2026
Primary completion
May 16, 2031
Completion
May 16, 2031

Study Design

Enrollment
87 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A) [ Time Frame: Cycle 1 (28 days) ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005PhoenixArizona85054-
Mayo Clinic in Florida- Site Number : 8400003JacksonvilleFlorida32224-
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004RochesterMinnesota55905-
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001HackensackNew Jersey07601-
Thomas Jefferson University Hospital- Site Number : 8400002PhiladelphiaPennsylvania19107-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic in Arizona - Phoenix· Phoenix, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester - Minnesota· Rochester, MNHackensack Meridian Health - Hackensack University Medical Center· Hackensack, NJThomas Jefferson University Hospital· Philadelphia, PA

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