Actively Recruiting
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2024-12-13
116
Participants Needed
13
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older. For dose escalation (Part 1), age 18 to 75 years.
- Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
- ECOG Performance Status score of 0 or 1.
- Life expectancy of at least 3 months.
- Ability to understand and give written informed consent for participation in the trial and all procedures.
You will not qualify if you...
- Known active central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
- Diagnosis of amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, solitary plasmacytoma, or smoldering multiple myeloma.
- Spinal cord compression causing limited self-care within 6 months prior to consent or expected soon.
- History of primary immunodeficiency.
- Current or previous other malignancy within 3 years, except certain cured or noninvasive cancers such as basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, or carcinoma in situ of the cervix.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Wollongong Private Hospital
Wollongong, New South Wales, Australia, 2500
Suspended
2
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Suspended
3
St Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Suspended
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
5
The first Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
6
Tongji Medical College of HUST Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
7
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
8
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Not Yet Recruiting
9
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Actively Recruiting
10
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
11
ZhongShan Hospital FuDan University
Shanghai, Shanghai Municipality, China, 201700
Actively Recruiting
12
The First Affiliated Hospital of XI'AN Jiaotong University
Xian, Shanxi, China, 710061
Not Yet Recruiting
13
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300050
Not Yet Recruiting
Research Team
S
Serena Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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