Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB2029 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB2029 injection
- description
- TQB2029 injection, 28 days as a treatment cycle.
- interventionNames
- Drug: TQB2029 injection
Primary outcomes (4)
- measure
- Dose Limiting Toxicities (DLT)
- timeFrame
- During the first 28 days
- description
- DLT refers to any of the following events in the first administration of TQB2029 for injection to the end of the first treatment cycle (C1D28) that the investigator and the sponsor consider to be related to the treatment of TQB2029 for injection.
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Up to 18 months
- description
- After the experiment is completed, sequential regression is used to determine the maximum tolerated dose (MTD). Specifically, calculate the toxicity rate of each dose group and select the dose closest to the target toxicity rate as MTD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available