Tests TQB2029 injection safety and dosing in multiple myeloma
Tests the new TQB2029 injection in adults with multiple myeloma, a blood cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Key facts
- Where
- Chengdu and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06700395, who can take part
Where in China
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- Zhongshan Hospital of Fudan UniversityShanghai, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Trial code
- NCT06700395
- Record updated
- 6 December 2024
- Original description
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.Read full original descriptionShow less
Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma
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.
Inclusion: 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.
Exclusion: Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration; Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication; Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication; Subjects who 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 surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication; Subjects who have experienced arterial/venous thrombotic event occurred within 6 months prior to the first administration; Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent; Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders; Subjects with any severe and/or uncontrolled disease; According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.