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NCT06375044 | RECRUITING | Relapsed or Refractory Multiple Myeloma

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

Jiangsu Simcere Pharmaceutical Co., Ltd.

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

Relapsed or Refractory Multiple Myeloma

Intervention/treatment

SIM0500

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
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
Actual Study Start Date : 2024-05-24
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2028-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

Location Details

NCT06375044

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Massachusetts

Dana Farber Cancer institution

Boston, Massachusetts, United States, 02215

RECRUITING

United States, New York

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

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

New York, New York, United States, 10029

RECRUITING

China, Beijing Municipality

Beijing Chaoyang Hospital Capital Medical University

Beijing, Beijing Municipality, China, 100000

RECRUITING

China, Guangdong

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510000

RECRUITING

China, Henan

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

RECRUITING

China, Tianjin Municipality

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

Tianjin, Tianjin Municipality, China, 300000

RECRUITING

China, Zhejiang

The First Affiliated Hospital Zhejiang University School of Medicine

Han Zhou, Zhejiang, China, 310000