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

NCT06700395 | Recruiting Phase 1

• 1 other identifier: TQB2029-I-01
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Dose Limiting Toxicities (DLT)

  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.

  During the first 28 days

• Maximum tolerated dose (MTD)

  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.

  Up to 18 months

• Recommended Phase II Dose (RP2D)

  Determine RP2D based on target toxicity rates for each dose group

  Up to 18 months

• Number of patients with adverse events (AEs) and serious adverse events (SAEs)

  Assessed by the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) v5.0.

  Up to 18 months

Secondary Outcomes (17)

• Elimination half-life (to be used in one-or non- compartmental model) (t1/2)

  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)

  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)

  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)

  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)

  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.

Study Arms (1)

TQB2029 injection

EXPERIMENTAL

TQB2029 injection, 28 days as a treatment cycle.

Drug: TQB2029 injection

Interventions

TQB2029 injection DRUG

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.

TQB2029 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

West China hospital, Sichuan university

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Ting Niu, Doctor

CONTACT

028-85423046; tingniu@sina.com

Peng Liu, Doctor

CONTACT

021-60267405; Liu.peng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: November 28, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-07

Locations

CN (2)