Spots Global Cancer Trial Database for First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
Official Title: 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)
Study ID: NCT04000282
Conditions
Interventions
Study Description
Brief 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
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number :8400002, Duarte, California, United States
Investigational Site Number :8400003, Boston, Massachusetts, United States
Investigational Site Number :8400005, Rochester, Minnesota, United States
Investigational Site Number :8400006, Chapel Hill, North Carolina, United States
Investigational Site Number :8400004, Milwaukee, Wisconsin, United States
Investigational Site Number :2030002, Brno, , Czechia
Investigational Site Number :2030003, Ostrava - Poruba, , Czechia
Investigational Site Number :2030001, Praha 2, , Czechia
Investigational Site Number :2500001, TOULOUSE Cedex 9, , France
Investigational Site Number :3000001, Athens, , Greece
Investigational Site Number :7240002, Hospitalet de Llobregat, Castilla Y León, Spain
Investigational Site Number :7240001, Salamanca, , Spain
Investigational Site Number :1580002, Taichung, , Taiwan
Investigational Site Number :1580001, Taipei, , Taiwan
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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