Recruiting
Phase 1

SIM0500

Sponsor:

Jiangsu Simcere Pharmaceutical Co., Ltd.

Code:

NCT06375044

Conditions

Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SIM0500

Study Details

Brief 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

Study ID

NCT06375044

Start date

May 24, 2024

Status verified date

Feb, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Voluntary participation and signature of informed consent form.
2. ≥18 years of age.
3. Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have failed all established standard of care.
4. Life expectancy ≥12 weeks.
5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
6. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
2. Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial.
3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
5. Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger, type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can be included.
6. Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
8. Participants with known active infection within 14 days prior to the first SIM0500.

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SIM0500

Interventions

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.

Primary outcome measure

  • Part 1: Number of Participants with Dose-limiting toxicity (DLT) [ Time Frame: From enrollment up to 35 days afterward ]
  • Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: From enrollment up to 24 months afterward ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Saurabh Chhabra, MD

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Principal Investigator:

Polina Bellman, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Sikander Ailawadhi, MD

Dana Farber Cancer institution

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Shaji Kumar, MD

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

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

Recruiting

New York, New York, United States, 10029

University of North Carolina Hospitals at Hillsborough

Recruiting

Hillsborough, North Carolina, United States, 27278

Principal Investigator:

Eben Lichtman, MD

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Jesus Berdeja, MD

More Information

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Last update posted

Aug 28, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jiangsu Simcere Pharmaceutical Co., Ltd. on 2026-08-28.