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No longer recruiting (closed or complete)Last updated: 20 June 2025

IBI3003: This study will evaluate the effectiveness, safety and recommended dose of a new drug (IBI3003) in people with multiple myeloma.A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 75

Trial acronym

IBI3003

Clinical summary

Summary

This study is a multicenter, open-label, first-in-human study of a new targeted therapy (IBI3003).

116 participants will take part is the study which is comprised of two phases.

Phase 1 (Does Escalation and Dose Expansion) will identify the maximum tolerated dose(MTD)/recommended Phase 2 Dose of IBI3003.

Participants will receive IBI3003 on Day 1 in a 28-day cycle.

Phase two will evaluate effectiveness, safety and tolerability of IBI3003 at the recommended dose (established in Phase 1).

Conditions

This trial is treating people with Multiple Myeloma

Eligibility

Inclusion

  • 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

  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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Scientific Title

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

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