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

Официальное название

Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma

Обзор

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.

Вмешательства

• Препарат TQB2029 injection
  TQB2029 for injection is a bispecific antibody targeting G Protein-Coupled Receptor, Class C, Group 5, Member D (GPRC5D) and Cluster of Differentiation 3 (CD3) . By recruiting and activating CD3 positive T cells, it induces T cells to kill malignant plasma cells expressing GPRC5D, thereby inhibiting the occurrence and development of tumors.

Первичные конечные точки

• Dose Limiting Toxicities (DLT) [Срок оценки: During the first 28 days]
• Maximum tolerated dose (MTD) [Срок оценки: Up to 18 months]
• Recommended Phase II Dose (RP2D) [Срок оценки: Up to 18 months]
• Number of patients with adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Up to 18 months]

Вторичные конечные точки (12)

• Elimination half-life (to be used in one-or non- compartmental model) (t1/2) [Срок оценки: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.]
• Maximum (peak) plasma drug concentration (Cmax) [Срок оценки: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.]
• Area under the plasma concentration-time curve from time zero to time t (AUC0-t) [Срок оценки: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.]
• Apparent clearance rate (CL/F) [Срок оценки: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.]
• Volume of distribution(Vz/F) [Срок оценки: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.]
• Blood drug trough concentration (Cmin) [Срок оценки: The first and second treatment cycle: 0 hours, 2 hours, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 168 hours after dosing on the first day, 0 hours on the 15th day, and 0 hours on the 22nd day.]
• Exploring the correlation between changes in cytokine levels, lymphocyte subpopulation levels, and therapeutic efficacy [Срок оценки: The first and second treatment cycle: 0, 2, 6, 24, 48, 72 hours after dosing on the first day, 0 hours on the 15th day;The first treatment cycle: 0 hours on the 8th day;0 hours on the 22th day;The third and fourth treatment cycle: 0 hours on the 1st day.]
• Immunogenicity analysis- positive anti drug antibodies (ADA) [Срок оценки: The first, third, sixth, twelfth treatment cycle: 0 hours on the first day;and End of Treatment Visit (EOT)]
• Overall response rate (ORR) [Срок оценки: Up to 18 months]
• Very good partial response rate (VGPR) [Срок оценки: Up to 18 months]
• Complete Response (CR) [Срок оценки: Up to 18 months]
• Strict Complete Response (sCR) Rate [Срок оценки: Up to 18 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Zhongshan Hospital of Fudan University — Шанхай
• West China hospital, Sichuan university — Чэнду

Идентификаторы

NCT: NCT06700395 · TQB2029-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗