First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL

STATUS

Recruiting
participants needed

57
sponsor

Sanofi

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Updated on 19 February 2024

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cancer

dexamethasone

ct scan

measurable disease

ejection fraction

chronic lymphocytic leukemia

lymphoma

hodgkin's disease

multiple myeloma

cancer treatment

core needle biopsy

follicular lymphoma

neuropathy

cancer therapy

recurrent disease

diffuse large b-cell lymphoma

excisional biopsy

cutaneous t-cell lymphoma

hair thinning

Summary

Primary Objective:

To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)

Secondary Objectives:

To characterize the safety profile of SAR442257 To characterize the pharmacokinetics (PK) profile of SAR442257 To evaluate the potential immunogenicity of SAR442257 To assess preliminary evidence of antitumor activity

Description

Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.

Details

Condition	Cancer, cancer/tumors, cancer (pediatric), ewing's family tumors, cancer (pediatric), ewing's family tumors, cancer/tumors
Age	18years - 100years
Treatment	SAR442257, Acetaminophen or equivalent (premedication), Ranitidine or equivalent (premedication), Diphenhydramine or equivalent (premedication), Montelukast (premedication), Dexamethasone (premedication)
Clinical Study Identifier	NCT04401020
Sponsor	Sanofi
Last Modified on	19 February 2024

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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
	Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group
	(ECOG) performance status 2
	RRMM patients
	must have received at least 3 prior lines of therapy including proteasome
	inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb; and must
	have received their last dose of prior anti-CD38 therapy within 9 months prior
	to the first dose of SAR442257; and must be refractory to anti-CD38 antibody
	(eg, daratumumab or isatuximab), characterized by progression within 60 days
	of the last dose of anti-CD38, regardless of which line it was given; and must
	be either relapsed or refractory to all established therapies with known
	clinical benefit in RRMM where approved and available, or are intolerant to
	those established therapies; and must not be candidates for regimens known to
	provide clinical benefit
	Patients with RRMM must have measurable disease as per the following
	Serum M protein 0.5 g/dL (5 g/L), or
	Urine M protein 200 mg/24 hours, or
	Serum free light chain (FLC) assay: involved FLC assay 10 mg/dL and an abnormal serum FLC ratio (<0.26 or >1.65)
	Patients with RR-NHL must be relapsed or refractory to all established
	therapies with known clinical benefit where approved and available, or are
	intolerant to those established therapies
	Patients with RR-NHL must have measurable disease of at least one lesion 1.5
	cm as documented by computed tomography (CT) scan, including the following
	subtype of disease
	Diffuse large B-cell lymphoma (DLBCL)
	transformed follicular lymphoma (tFL)
	follicular lymphoma (FL)
	mantle cell lymphoma (MCL)
	marginal zone lymphoma (MZL)
	lymphoplasmacytic lymphoma
	small lymphocytic lymphoma (SLL). Patients with RR-NHL subtype T cell lymphoma (TCL): histopathologically confirmed mycosis fungoides or Szary syndrome (cutaneous T cell lymphoma [CTCL] stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (ie, refractory) as determined by the Investigator
	Patients with lymphoma must have availability of lymphoma tissue for biomarker
	testing: either archived tissue or a fresh biopsy as a part of screening. On-
	treatment biopsy (Cycle 2 or beyond) is also expected if disease location is
	in a superficial lymph node. Excisional biopsy or resected tissue is required
	if clinically feasible; otherwise, core needle biopsy is acceptable. Fine
	needle aspirates are not acceptable
	Patients with lymphoma must have a 50% left ventricular ejection fraction
	(LVEF) and no pericardial effusion, as measured by echocardiogram (ECHO)
	Contraceptive use by men or women should be consistent with local regulations
	regarding the methods of contraception for those participating in clinical
	studies
Exclusion Criteria
	Diagnosed or treated for another malignancy within 3 years prior to
	enrollment, except for basal cell carcinoma or squamous cell carcinoma of the
	skin, an in-situ malignancy, superficial bladder carcinoma or low risk
	prostate cancer
	Amyloidosis, leukemic manifestations of lymphoma, chronic lymphocytic leukemia
	and Richter's transformation, and prolymphocytic leukemia
	Known central nervous system (CNS) involvement by myeloma, lymphoma or other
	CNS disease such as neurodegenerative condition or CNS movement disorder
	Has congestive heart failure (New York Heart Association) Grade II
	cardiomyopathy, 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). Acute
	myocardial infarction within 6 months before start of study treatment
	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
	Clinically-not controlled chronic or ongoing infectious disease requiring
	treatment at the time of first dose or within the 14 days before first dose
	Active hepatitis A, B, and C as defined below: active hepatitis A (defined as
	positive IgM), active hepatitis B (defined as either positive hepatitis B
	surface antigen or positive hepatitis B viral DNA test above the lower limit
	of detection of the assay, and hepatitis B core antibodies), or C infection
	(defined as a known positive hepatitis C antibody result and known
	quantitative hepatitis C [HCV] ribonucleic acid [RNA] results greater than the
	lower limits of detection of the assay)
	Known positivity for Human Immunodeficiency Virus (HIV). Unresolved toxicities
	from prior anticancer therapy, defined as not having resolved to Common
	Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 1 or to
	levels dictated in the eligibility criteria with the exception of Grade 1
	peripheral neuropathy, alopecia or toxicities from prior anticancer therapy
	that are considered irreversible (defined as having been present and stable
	for >4 weeks) which may be allowed if they are not otherwise described in the
	exclusion criteria
	Participant not suitable for participation, whatever the reason, as judged by
	the Investigator, including medical or clinical conditions, or participants
	potentially at risk of noncompliance to study procedures
	Sensitivity to any of the study interventions, or components thereof, or drug
	or other allergy that, in the opinion of the Investigator, contraindicates
	participation in the study
	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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First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL