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

NCT06375044 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-06

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shanghai Xianxiang Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2026-06-30
Completion
2028-12-30
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375044 on ClinicalTrials.gov