NCT06375044

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

A Phase I First-in-human, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500, A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-05-24
• Primary completion: 2026-06-30
• Completion: 2028-12-30
• First posted: 2024-04-19
• Last updated: 2026-03-06

Locations

11 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study