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

Last updated: February 27, 2025
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Cancer/tumors

Lymphoproliferative Disorders

Treatment

SIM0500

Clinical Study ID

NCT06375044
SIM0500-101
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 toCriteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria whohave 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

Exclusion Criteria:

  1. Toxicities from previous anticancer therapies should have resolved to baselinelevels 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 ≥ 2,000international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN)infection; participant with HBsAg positive or detective HBV-DNA at screening shouldreceive antiviral treatment as per local practice during the trial.

  3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiencysyndrome (AIDS).

  4. Participant is pregnant or breastfeeding, or expecting to conceive or fatherchildren within the projected duration of the trial.

  5. Active known or suspected autoimmune disease. Participants with vitiligo, residualhypothyroidism only requiring hormone replacement, psoriasis not requiring systemictreatment 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 beincluded.

  6. Current or previous other malignancy within 3 years of study entry, except basal orsquamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of theprostate, cervix or breast.

  7. Known active central nervous system (CNS) involvement or exhibits clinical signs ofmeningeal involvement of multiple myeloma.

  8. Participants with known active infection within 14 days prior to the first SIM0500.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: SIM0500
Phase: 1
Study Start date:
May 24, 2024
Estimated Completion Date:
December 30, 2028

Connect with a study center

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

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

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hanzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Dana Farber Cancer institution

    Boston, Massachusetts 02215
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Active - Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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