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

PHASE1PHASE2RECRUITING

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 6 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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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.

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.

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.

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-30

Primary completion: 2028-11-13

Study completion finish: 2029-05-14

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT06630806

Intervention or treatment

DRUG: SAR446523

Conditions

• Plasma Cell Myeloma Refractory

$Image related to Plasma Cell Myeloma Refractory$

Condition: Plasma Cell Myeloma Refractory
DRUG: SAR446523
Wollongong, New South Wales, Australia
Sponsor: Sanofi

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Find a site

Closest Location:

Investigational Site Number : 0360001

Research sites nearby

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Investigational Site Number : 0360001
Wollongong, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A (Dose escalation) Participants will receive SAR446523	DRUG: SAR446523 Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
EXPERIMENTAL: Part B Dose-1 (Dose optimization) Participants will receive SAR446523 Dose-1	DRUG: SAR446523 Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
EXPERIMENTAL: Part B Dose-2 (Dose optimization) Participants will receive SAR446523 Dose-2	DRUG: SAR446523 Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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
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 90 days after the date of the last study treatment administration i.e., approximately 5 years

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References

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