Actively Recruiting
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2024-12-06
136
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.
CONDITIONS
Official Title
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
- Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period.
- Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria
- There are measurable lesions present
- The function of main organs is normal.
- Subjects need to adopt effective methods of contraception.
You will not qualify if you...
- Subjects who have taken Chinese patent medicines with anti-tumor indications approved by the National Medical Products Administration within 2 weeks before the first administration.
- Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication
- Subjects known to be allergic to any of the study medications, their analogues, or excipients in any formulation.
- Subjects who have had or currently have other malignant tumors within the past 3 years prior to the first medication
- Subjects with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment
- Subjects who have undergone major surgery, significant traumatic injury, or expect major surgery during the study treatment period within 4 weeks prior to first medication
- Subjects who experienced arterial or venous thrombotic events within 6 months prior to first administration
- Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders
- Subjects with any severe and/or uncontrolled disease
- Subjects with accompanying diseases that seriously endanger safety or affect study completion according to investigator judgment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
2
West China hospital, Sichuan university
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
T
Ting Niu, Doctor
CONTACT
P
Peng Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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