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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study ID
NCT06375044
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 19, 2024
Start date
May 24, 2024
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SIM0500

Primary Outcome Measure

Part 1: Number of Participants with Dose-limiting toxicity (DLT) [ Time Frame: From enrollment up to 35 days afterward ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Clinical Trials Referral Office
855-776-0015
Saurabh Chhabra, MD (PRINCIPAL_INVESTIGATOR)
UC Irvine HealthOrangeCalifornia92868
Polina Bellman, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
855-776-0015
Sikander Ailawadhi, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer institutionBostonMassachusetts02215
Shonali Midha
[email protected]
855-776-0015
Mayo Clinic RochesterRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Shaji Kumar, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount Sinai，The Tisch Cancer InstituteNew YorkNew York10029
Mt. Sinai
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
NYU
University of North Carolina Hospitals at HillsboroughHillsboroughNorth Carolina27278
Eben Lichtman, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Jesus Berdeja, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic Arizona· Phoenix, AZUC Irvine Health· Orange, CAMayo Clinic Florida· Jacksonville, FLDana Farber Cancer institution· Boston, MAMayo Clinic Rochester· Rochester, MNIcahn School of Medicine at Mount Sinai，The Tisch Cancer Institute· New York, NY

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