NCT06700395RecruitingPhase 1
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 28 Nov 2024
- Primary completion date
- Mar 2026
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Diseases
- Multiple myeloma
- NCT number
- NCT06700395
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 136
- From 28 Nov 2024 to the primary completion date, Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Zhongshan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.