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)
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
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.
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