Spots Global Cancer Trial Database for First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
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Trial Identification
Brief Title: First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
Official Title: 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
Study ID: NCT04401020
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Praha 2, , Czechia
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 5780001, Oslo, , Norway
Investigational Site Number : 5780101, Oslo, , Norway
Investigational Site Number : 7240005, Santander, Cantabria, Spain
Investigational Site Number : 7240003, Badalona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240006, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240001, Pamplona, Navarra, Spain
Investigational Site Number : 7240007, Madrid, , Spain
Investigational Site Number : 7240004, Valencia, , Spain
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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