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Clinical Trials in China / NCT06375044
Recruiting Phase 1

Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

NCT06375044 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2024-05-24
Last updated
2026-08-28

Condition(s) studied

Relapsed or Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

SIM0500

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Voluntary participation and signature of informed consent form. 2. ≥18 years of age. 3. 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. 4. Life expectancy ≥12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 6. Adequate hematologic, hepatic, and renal function. Exclusion Criteria: 1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy. 2. Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial. 3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial. 5. Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger, type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can be included. 6. Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast. 7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 8. Participants with known active infection within 14 days prior to the first SIM0500.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
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

Official registry record

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