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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
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.
Mayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGPart 1: Number of Participants with Dose-limiting toxicity (DLT)
DLTs are defined as specific non-hematologic toxicity, or hematologic toxicity
Time frame: From enrollment up to 35 days afterward
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from grade 1 to Grade 5.
Time frame: From enrollment up to 24 months afterward
Pharmacokinetics (PK) of SIM0500
Serum samples will be analyzed to determine concentrations of SIM0500
Time frame: From enrollment up to 24 months afterward
Immunogenicity of SIM0500
Number of participants with presence of anti-drug antibodies to SIM0500 will be reported
Time frame: From enrollment up to 24 months afterward
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UC Irvine Health
Orange, California, United States
RECRUITINGMayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGDana Farber Cancer institution
Boston, Massachusetts, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGLaura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
RECRUITINGIcahn School of Medicine at Mount Sinai,The Tisch Cancer Institute
New York, New York, United States
RECRUITINGUniversity of North Carolina Hospitals at Hillsborough
Hillsborough, North Carolina, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
RECRUITINGBeijing Chaoyang Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITING...and 6 more locations