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 (11) 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
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Massachusetts
Dana Farber Cancer institution
NOT_YET_RECRUITING
Boston
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
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
Other Locations
China
Beijing Chaoyang Hospital Capital Medical University
RECRUITING
Beijing
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hanzhou
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences