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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06375044
Recruitment Status : Not yet recruiting
First Posted : April 19, 2024
Last Update Posted : April 19, 2024
Sponsor:
Collaborator:
Shanghai Xianxiang Medical Technology Co., Ltd.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: SIM0500 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 30, 2024
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : December 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: SIM0500 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.


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06375044


Contacts
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Contact: Juan Wen Wang 18630999743 wangwenjuan4@zaiming.com

Locations
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China, Tianjin
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin, China, 300000
Contact: Yan Xu       xuyan1@ihcams.ac.cn   
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Shanghai Xianxiang Medical Technology Co., Ltd.
More Information
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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT06375044    
Other Study ID Numbers: SIM0500-101
First Posted: April 19, 2024    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases