A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

December 12, 2024 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 23~116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Suspended
        • Wollongong Private Hospital
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Suspended
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3065
        • Suspended
        • St Vincent's Hospital
  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Medical College of Hust Tongji Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215006
        • Not yet recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 201700
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300050
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects in Parts 1(dose escalation) & 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:

    1. Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
    2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. Multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events in protocol
    3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
    4. Life expectancy ≥3 months.
    5. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

Exclusion Criteria:

  1. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  2. Have amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering MM as defined by the International Myeloma Working Group(IMWG) criteria.
  3. Spinal cord compression that results in limited self-care occurs within 6 months prior to informed consent, or is expected to occur in the near future.
  4. History of primary immunodeficiency.
  5. Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI3003
Drug: IBI3003
Subjects will receive IBI3003 on Day 1 in a 28-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and pharmacokinetic(PK) data), until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: Up to 30 days post last dose
Number of patients who Experienced related AEs from the first dose until 30 days after the last dose
Up to 30 days post last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicities (DLTs)
Time Frame: Up to 28 days post first dose
To evaluate the safety and tolerability of IBI3003
Up to 28 days post first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI3003A101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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