Testing IBI3003 for patients with relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2 multicenter, open-label study evaluating IBI3003 in patients with relapsed or refractory multiple myeloma. The study consists of a dose escalation phase to determine the maximum tolerated dose and a subsequent phase to assess the efficacy, safety, and tolerability of IBI3003 at the recommended dose. It aims to enroll between 23 to 116 subjects who meet specific eligibility criteria related to their condition and overall health.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Medical College of HUST Tongji Hospital
  Wuhan, Hubei, China Recruiting
• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting
• ZhongShan Hospital FuDan University
  Shanghai, Shanghai Municipality, China Recruiting
• Wollongong Private Hospital
  Wollongong, New South Wales, Australia Suspended
• Austin Hospital
  Heidelberg, Victoria, Australia Suspended
• St Vincent's Hospital
  Melbourne, Victoria, Australia Suspended

Study contacts

• Study coordinator: Serena Dong
• Email: suhua.dong@innoventbio.com
• Phone: 0512 69566088

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.