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

Jiangsu Simcere Pharmaceutical Co., Ltd.17 sites in 2 countries130 target enrollmentMay 24, 2024

ConditionsRelapsed or Refractory Multiple Myeloma

InterventionsSIM0500

DrugsSIM0500

Overview

Phase: Phase 1
Intervention: SIM0500
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Enrollment: 130
Locations: 17
Primary Endpoint: Dose-limiting toxicity (DLT)
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 24, 2024

End Date

December 30, 2028

Last Updated

last month

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation and signature of informed consent form.
•≥18 years of age.
•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.
•Life expectancy ≥12 weeks.
•Eastern Cooperative Oncology Group (ECOG) score of 0 or
•Adequate hematologic, hepatic, and renal function.

Exclusion Criteria

•Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
•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.
•Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
•Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
•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.
•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.
•Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
•Participants with known active infection within 14 days prior to the first SIM0500.