RecruitingPhase 1NCT06375044

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


Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

130 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new drug called SIM0500 in people with relapsed or refractory multiple myeloma (a blood cancer in the bone marrow) who have already tried all available standard treatments without success. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of multiple myeloma - Your myeloma has come back or stopped responding to all standard treatments - Your overall health status is adequate (ECOG 0 or 1) - Your blood counts and organ function meet minimum thresholds - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have active hepatitis B or C - You have side effects from prior treatments that have not resolved to mild levels (Grade 1 or less) - You have had certain prior therapies or conditions that conflict with this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSIM0500

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

View Full Details on ClinicalTrials.gov

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NCT06375044


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