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

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 Criteria:

• 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 Criteria:

• 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
• 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 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.