Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration.

Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous

SAR442085

Clinical Sciences & Operations

Primary Objectives:

* Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B
* Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM

Secondary Objectives:

* To characterize the safety profile of SAR442085
* To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent
* To evaluate the potential immunogenicity of SAR442085
* To assess preliminary evidence of antitumor activity in the Dose Escalation Part A

Patient will continue to receive study medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason why investigator considers it appropriate to discontinue study medication. Once permanently discontinued, study medication cannot be restarted at later timepoint.

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

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

MTD is defined as the dose level with highest probability of investigational medicinal product (IMP) related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (\>33%)

RP2D is defined as the dose selected for the further single agent testing - including in Phase 1 expansion part B.

Overall response rate (ORR): is defined as the proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), using the International Myeloma Working Group (IMWG) criteria.

Number of participants with Treatment-Emergent Adverse events (TEAEs) from baseline to End of Study.

Maximum plasma concentration observed (Cmax).

Area under the plasma concentration versus time curve extrapolated to infinity (AUC).

Number of participants with ADA against SAR442085.

Progression-free survival (PFS) is defined as the time interval from the date of enrollment to the date of documented tumor progression as per IMWG or death (due to any cause), whichever comes first.

Duration of response (DOR) is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as per IMWG or death from any cause, whichever occurs first.

Spots Global Cancer Trial Database for sar442085

Every month we try and update this database with for sar442085 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sar442085

Every month we try and update this database with for sar442085 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sar442085 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.