Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Part 1: Number of Participants with Dose-limiting toxicity (DLT) — From enrollment up to 35 days afterward
DLTs are defined as specific non-hematologic toxicity, or hematologic toxicity - Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity — From enrollment up to 24 months afterward
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.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | Recruiting |
| UC Irvine Health | Orange | California | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| Dana Farber Cancer institution | Boston | Massachusetts | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | Recruiting |
| Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute | New York | New York | Recruiting |
| University of North Carolina Hospitals at Hillsborough | Hillsborough | North Carolina | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | Recruiting |
| Beijing Chaoyang Hospital Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of FuJian Medical University | Fuzhou | Fujian | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | Recruiting |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine | Hanzhou | Zhejiang | Recruiting |
More Jiangsu Simcere Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06375044 on ClinicalTrials.gov ↗ ← All trials in China