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First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

An Open-label, First-in-human, Single Agent, Dose Escalation Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442257 in Patients With Relapsed and Refractory Multiple Myeloma and Relapsed and Refractory Non-Hodgkin Lymphoma

NCT04401020•Sanofi

View on ClinicalTrials.gov

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 relapsed 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 assess preliminary evidence of antitumor activity

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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; based upon investigator's clinical judgement.
•and must not be candidates for regimens known to provide clinical benefit based upon investigator's clinical judgement.
•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).
+13 more criteria

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, chronic lymphocytic leukemia 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).
•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.

Locations (16)

City of Hope Site Number : 8400001

Duarte, California, United States

University of Miami - Sylvester Comprehensive Cancer Center Site Number : 8400005

Miami, Florida, United States

Mayo Clinic of Rochester Site Number : 8400003

Rochester, Minnesota, United States

Investigational Site Number : 2030003

Brno, Czechia

Investigational Site Number : 2030001

Ostrava - Poruba, Czechia

Investigational Site Number : 2030002

Prague, Czechia

Investigational Site Number : 5780001

Oslo, Norway

Investigational Site Number : 5780101

Oslo, Norway

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Key Dates

Start Date

July 24, 2020

Primary Completion Date

March 2, 2024

Completion Date

March 17, 2026

Last Updated

March 21, 2025

Enrollment

ACTUAL participants

Conditions

Neoplasm Malignant

Interventions

SAR442257

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

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Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

Study of the Impact of DPD Activity on the Efficacy of Capecitabine

Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors