SAR446523 for Multiple Myeloma

Recruiting at 9 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sanofi

Must not be taking: NK-cell therapy

Disqualifiers: Amyloidosis, POEMS syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

82 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic antimyeloma treatment at least 14 days before starting the study treatment. If you've had NK-cell engaging therapy, you need to wait 90 days before starting the trial.

What makes the drug SAR446523 unique for treating multiple myeloma?

The drug SAR446523 is unique for treating multiple myeloma because it represents a novel therapeutic approach that may target specific genetic abnormalities and oncogenic pathways involved in the disease, potentially offering a more personalized treatment option compared to existing therapies. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with relapsed/refractory multiple myeloma (RRMM) who have tried at least three prior treatments, including specific drugs like immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies. For part B of the study, patients previously treated with anti-GPRC5D therapies can't participate.

Inclusion Criteria

My previous cancer treatments either didn't work, stopped working, or I couldn't tolerate them.

My previous cancer treatments either didn't work, stopped working, or caused side effects I couldn't tolerate.

I have been diagnosed with multiple myeloma and it can be measured.

Exclusion Criteria

Participants with significant concomitant illness

I haven't had any myeloma treatment in the last 14 days.

I need some help with daily activities due to my health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Participants receive SAR446523 to determine the maximum administered dose, maximum tolerated dose, and recommended dose range

28 days per cycle

Multiple visits per cycle

Dose Optimization (Part B)

Participants are randomly assigned to one of the chosen dose regimens to determine the optimal dose as the recommended phase 2 dose

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months after the last participant in

Treatment Details

Interventions

• SAR446523

Trial Overview The trial tests SAR446523 in RRMM patients. It has two parts: Part A finds the safest high dose by testing up to six levels; Part B uses that info to find the best dose for future studies. Patients are randomly assigned a dosage regimen in Part B.

Participant Groups

Group I: Part B Dose-2 (Dose optimization) Experimental Treatment 1 Intervention

Participants will receive SAR446523 Dose-2

Group II: Part B Dose-1 (Dose optimization) Experimental Treatment 1 Intervention

Participants will receive SAR446523 Dose-1

Group III: Part A (Dose escalation) Experimental Treatment 1 Intervention

Participants will receive SAR446523

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Findings from Research

Research into the cellular mechanisms of multiple myeloma has led to new treatment strategies, particularly targeting the role of interleukin-6 in disease progression, which can inhibit myeloma cell growth.

Pamidronate has been effective in reducing skeletal complications in patients with advanced myeloma, highlighting its therapeutic potential in managing the disease's adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the biology and treatment of multiple myeloma. Varterasian, ML.[2019]

Multiple myeloma (MM) is a complex cancer characterized by genetic abnormalities that affect various oncogenic pathways, making it a challenging disease to treat.

Recent advancements in treatment, including immunomodulatory drugs like thalidomide and lenalidomide, and proteasome inhibitors like bortezomib, have improved patient outcomes, but MM remains incurable for most, highlighting the need for ongoing research into new therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapy of multiple myeloma. Dolloff, NG., Talamo, G.[2022]

Multiple myeloma (MM) is characterized by the malignant growth of B-lymphocytes and is associated with various organ damage due to the production of monoclonal components, leading to complications like renal failure and bone disease.

Current treatments for MM include alkylating agents and glucocorticoids, while bisphosphonates have emerged as an effective option for managing bone disease associated with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple myeloma. Ascari, E., Merlini, G., Riccardi, A.[2005]

Multiple myeloma (MM) presents significant treatment challenges, especially for high-risk patients and those with multi-drug resistant disease, highlighting the need for novel anti-MM agents and personalized treatment strategies.

Identifying specific molecular lesions in different myeloma subtypes and utilizing advanced molecular profiling techniques are crucial for developing effective, tailored therapies and improving patient outcomes in MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future directions of next-generation novel therapies, combination approaches, and the development of personalized medicine in myeloma. Mitsiades, CS., Davies, FE., Laubach, JP., et al.[2023]

Over 20 years of research and analysis of more than 1000 multiple myeloma genomes have led to a better understanding of the disease's development and potential treatment targets.

The review emphasizes the need to translate genetic and biological insights into clinical practice, suggesting a framework for using targeted therapies and risk stratification to enhance patient management in multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Bench to Bedside: The Evolution of Genomics and Its Implications for the Current and Future Management of Multiple Myeloma. Morgan, GJ., Boyle, EM., Davies, FE.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Advances in the biology and treatment of multiple myeloma. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Targeted therapy of multiple myeloma. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Multiple myeloma. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Future directions of next-generation novel therapies, combination approaches, and the development of personalized medicine in myeloma. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

From Bench to Bedside: The Evolution of Genomics and Its Implications for the Current and Future Management of Multiple Myeloma. [2021]