Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-08-12
notable Trial sites expanded: 11 -> 14 locations 2026-08-12
notable Primary completion pushed: 2026-06-30 -> 2027-09-30 2026-08-12
Trial Details
NCT Number NCT06375044
Lead Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Shanghai Xianxiang Medical Technology Co., Ltd.
Conditions Relapsed or Refractory Multiple Myeloma
Enrollment 130 participants
Start Date 2024-05-24
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11