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Trial Title:
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT06375044
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SIM0500
Description:
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.
Arm group label:
SIM0500
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Xu
Email:
xuyan1@ihcams.ac.cn
Start date:
May 24, 2024
Completion date:
December 30, 2028
Lead sponsor:
Agency:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Shanghai Xianxiang Medical Technology Co., Ltd.
Agency class:
Other
Source:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06375044
