About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication
Trial design
Treatments tested in this trial
- TQB2029 injection