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Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.
Official title: A Phase I First-in-human, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500, A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-05-24
Completion Date
2028-12-30
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
SIM0500
Participants will receive SIM0500 in a 28-day cycle until disease progression, intolerable toxicity, or until the participant voluntarily withdraws from trial intervention, or end of study, whichever comes first.
Locations (11)
Mayo Clinic Arizona
Phoenix, Arizona, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Dana Farber Cancer institution
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute
New York, New York, United States
Beijing Chaoyang Hospital Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang, China