Trial Title:
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT06083207
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI3003
Description:
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.
Arm group label:
IBI3003
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wollongong Private Hospital
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Peter Presgrave
Phone:
+612 42534009
Email:
Peter.presgrave@health.nsw.gov.au
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13910118511
Phone ext:
010-69151188
Email:
zhuangjunling@pumch.cn
Facility:
Name:
The first Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13877179705
Phone ext:
0771- 535 9339
Email:
873215318@qq.com
Facility:
Name:
Tongji Medical College of HUST Tongji Hospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13647233185
Phone ext:
027-83662640
Email:
cunrui5650@126.com
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13770720898
Phone ext:
25-2583718836
Email:
quxiaoyan205@163.com
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13962191404
Phone ext:
512-6522 3637
Email:
fuzhengzheng@suda.edu.cn
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221002
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
18052268668
Phone ext:
0516-85802000
Email:
lizhenyumd@163.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13870659916
Phone ext:
0791-88313626
Email:
18907001021@163.com
Facility:
Name:
ZhongShan Hospital FuDan University
Address:
City:
Shanghai
Zip:
201700
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13817692514
Phone ext:
86-21-64041990
Email:
liu.peng@zs-hospital.sh.cn
Facility:
Name:
The First Affiliated Hospital of XI'AN Jiaotong University
Address:
City:
Xian
Zip:
710061
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
18991232609
Phone ext:
29-85323211
Email:
hepc_gcp@163.com
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300050
Country:
China
Status:
Not yet recruiting
Contact:
Phone:
13920350233
Phone ext:
022-60362255
Email:
furong8369@tmu.edu.cn
Start date:
July 29, 2024
Completion date:
October 31, 2027
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06083207
