Clinical trial NCT06700395: A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Official title: Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Dose Limiting Toxicities (DLT)
timeFrame: During the first 28 days
measure: Maximum tolerated dose (MTD)
timeFrame: Up to 18 months
measure: Recommended Phase II Dose (RP2D)
timeFrame: Up to 18 months
measure: Number of patients with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Elimination half-life (to be used in one-or non- compartmental model) (t1/2)
timeFrame: 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.
measure: Maximum (peak) plasma drug concentration (Cmax)
timeFrame: 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.
measure: Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
timeFrame: 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.
measure: Apparent clearance rate (CL/F)
timeFrame: 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.
measure: Volume of distribution(Vz/F)
timeFrame: 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.
measure: Blood drug trough concentration (Cmin)
timeFrame: 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.
measure: Exploring the correlation between changes in cytokine levels, lymphocyte subpopulation levels, and therapeutic efficacy
timeFrame: 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.
measure: Immunogenicity analysis- positive anti drug antibodies (ADA)
timeFrame: The first, third, sixth, twelfth treatment cycle: 0 hours on the first day;and End of Treatment Visit (EOT)
measure: Overall response rate (ORR)
timeFrame: Up to 18 months
measure: Very good partial response rate (VGPR)
timeFrame: Up to 18 months
measure: Complete Response (CR)
timeFrame: Up to 18 months
measure: Strict Complete Response (sCR) Rate
timeFrame: Up to 18 months
measure: Negative rate of minimal residual disease (MRD)
timeFrame: Up to 18 months
measure: Duration of remission (DOR)
timeFrame: Up to 18 months
measure: Time to first remission (TTR)
timeFrame: Up to 18 months
measure: Progression-free survival (PFS)
timeFrame: Up to 18 months
measure: Overall survival (OS)
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China hospital, Sichuan university
state: Sichuan
Study officials:
References: