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

Relapsed or Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375044
• Other study ID #: SIM0500-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 30, 2024
• Est. completion date: December 30, 2028

Study information

• Verified date: April 2024
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Juan Wen Wang
• Phone: 18630999743
• Email: wangwenjuan4[@]zaiming.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 30, 2028
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.	Shanghai Xianxiang Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)		At the end of Cycle 1 (each cycle is 28 days)