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

Recruiting now · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06083207

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

116

Starts

2024-07-29

Expected to finish

2027-10-31

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects in Parts 1(dose escalation) \& 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:
• Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Life expectancy ≥3 months.
• 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.

You may not qualify if…

• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• 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.
• 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.
• History of primary immunodeficiency.
• 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 is running

• ZhongShan Hospital FuDan University — Shanghai, Shanghai Municipality, China (enrolling)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)
• Tongji Medical College of HUST Tongji Hospital — Wuhan, Hubei, China (enrolling)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• The first Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China
• The First Affiliated Hospital of XI'AN Jiaotong University — Xian, Shanxi, China
• Wollongong Private Hospital — Wollongong, New South Wales, Australia
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China
• Austin Hospital — Heidelberg, Victoria, Australia
• St Vincent's Hospital — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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