Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
Voluntary participation and signature of informed consent form.
≥18 years of age.
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.
Life expectancy ≥12 weeks.
Disqualifiers
Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
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.
Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
Trial design
Treatments tested in this trial
- SIM0500
Treatment groups
130 Participants
are divided into 1 treatment groupSponsors and collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov