A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma

CTTQ

Status and phase

Enrolling

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: TQB2029 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06700395

TQB2029-I-01

Details and patient eligibility

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.

Enrollment

136 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.