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RECRUITING
NCT06375044
PHASE1

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

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-05-24

Completion Date

2028-12-30

Last Updated

2026-03-06

Healthy Volunteers

No

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.

Locations (11)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Dana Farber Cancer institution

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute

New York, New York, United States

Beijing Chaoyang Hospital Capital Medical University

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hanzhou, Zhejiang, China