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

  • STATUS
    Recruiting
  • End date
    May 20, 2023
  • participants needed
    78
  • sponsor
    Sanofi
Updated on 20 June 2021
monoclonal antibodies
measurable disease
cell transplantation
lenalidomide
thalidomide
bortezomib
monoclonal protein
line of therapy
carfilzomib
daratumumab
proteasome inhibitor
refractory multiple myeloma
ixazomib
pomalidomide
immunotherapeutic agent

Summary

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

Description

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment SAR442085
Clinical Study IdentifierNCT04000282
SponsorSanofi
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent
Participant has given voluntary written informed consent
Participant has been previousy diagnosed with multiple myeloma based on standard criteria
Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards
Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody
Participant has myeloma disease progression on or after last therapy
Participant must have measurable disease as defined as at least one of the following
Serum M protein 0.5 g/dL (5 g/L)
Urine M protein 200 mg/24 hours
Serum FLC assay: Involved FLC assay 10 mg/dL (100 mg/L) and an abnormal serum
FLC ratio (<0.26 or >1.65)
A male participant must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug and refrain from donating sperm during this period
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies
Not a woman of childbearing potential (WOCBP)
A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 150 days after the last dose of study intervention

Exclusion Criteria

Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score >2\
Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma
Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade 1 or baseline (exception: alopecia)
Participant has congestive heart failure (New York Heart Association) Grade II; cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method >480 msec (Grade 2)
Participant has had acute myocardial infarction within 6 months before first dose of study medication
Participant has ongoing sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3
Participant has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily
Known acquired immunodeficiency syndrome (AIDS) or related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or to have active hepatitis A, B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA), or C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen) infection
Participant has positive Coombs test at baseline
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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