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

ConditionRelapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SIM0500

    Drug

    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.

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: SIM0500Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants with Dose-limiting toxicity (DLT)

DLTs are defined as specific non-hematologic toxicity, or hematologic toxicity

Time frame
From enrollment up to 35 days afterward
2

Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from grade 1 to Grade 5.

Time frame
From enrollment up to 24 months afterward

Secondary outcomes

1

Pharmacokinetics (PK) of SIM0500

Serum samples will be analyzed to determine concentrations of SIM0500

Time frame
From enrollment up to 24 months afterward
2

Immunogenicity of SIM0500

Number of participants with presence of anti-drug antibodies to SIM0500 will be reported

Time frame
From enrollment up to 24 months afterward

Other outcomes

Sponsors and contacts

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Jiangsu Simcere Pharmaceutical Co., Ltd.

Lead sponsor

Shanghai Xianxiang Medical Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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