Evaluating SIM0500 for patients 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

This study is testing a new drug called SIM0500 to see if it can help adults with relapsed or refractory multiple myeloma who haven't had success with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (industry)
• Locations: 11 sites (Phoenix, Arizona and 10 other locations)
• Trial ID: NCT06375044 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase 1 clinical trial aims to assess the safety, tolerability, efficacy, and pharmacokinetics of SIM0500 in adults diagnosed with relapsed or refractory multiple myeloma. The trial consists of two parts: a dose escalation phase and a dose optimization phase, where participants will receive SIM0500 until disease progression, intolerable toxicity, withdrawal of consent, or the end of the trial. Participants must meet specific eligibility criteria, including having failed all standard treatments for their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of relapsed or refractory multiple myeloma who have failed all established standard of care.

Not a fit: Patients with active hepatitis B or C infections, or those with known HIV, may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with relapsed or refractory multiple myeloma who have exhausted existing therapies.

How similar studies have performed: Other studies have shown promise in targeting similar conditions, but the specific approach with SIM0500 is novel.

Eligibility 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.

Where this trial is running

Phoenix, Arizona and 10 other locations

• Mayo Clinic Arizona — Phoenix, Arizona, United States (RECRUITING)
• Mayo Clinic Florida — Jacksonville, Florida, United States (RECRUITING)
• Dana Farber Cancer institution — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (RECRUITING)
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (RECRUITING)
• Icahn School of Medicine at Mount Sinai，The Tisch Cancer Institute — New York, New York, United States (RECRUITING)
• Beijing Chaoyang Hospital Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (RECRUITING)
• The First Affiliated Hospital Zhejiang University School of Medicine — Hanzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Study Contact

Conditions: Relapsed or Refractory Multiple Myeloma