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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Voluntary participation and signature of informed consent form.
• ≥18 years of age.
• Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have failed all established standard of care.
• Life expectancy ≥12 weeks.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
• Adequate hematologic, hepatic, and renal function.
Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
California
UC Irvine Health
RECRUITING
Orange
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Massachusetts
Dana Farber Cancer institution
RECRUITING
Boston
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
University of North Carolina Hospitals at Hillsborough
RECRUITING
Hillsborough
New York
Icahn School of Medicine at Mount Sinai，The Tisch Cancer Institute
RECRUITING
New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Other Locations
China
Beijing Chaoyang Hospital Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital of FuJian Medical University
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hanzhou
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences