Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

NCT06188624 | Recruiting Phase 1

• 1 other identifier: TQB2922-I-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 17

Brief Summary

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT)

  DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred.

  During the first treatment cycle (28 days).

• Maximum tolerated dose (MTD)

  MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

  During the first treatment cycle (28 days).

• Adverse events (AEs) rate

  The occurrence rate of all AEs during treatment

  From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.

• Adverse events (AEs) severity

  The severity of all AEs occured during treatment

  From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.

Secondary Outcomes (9)

• Half-life (T1/2)

  Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

• The area under the curve (AUC)

  Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

• Apparent plasma clearance (CL)

  Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

• Apparent volume of distribution (Vz)

  Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

• Minimum concentration (Cmin)

  Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.

Study Arms (1)

TQB2922 for injection

EXPERIMENTAL

TQB2922 for injection, 28 days as a treatment cycle

Drug: TQB2922 for injection

Interventions

TQB2922 for injection DRUG

TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle

TQB2922 for 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 voluntarily join this study, sign the informed consent form, and have good compliance；
• Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
• Histologically or cytologically diagnosed with advanced cancers;
• Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;
• Major organs are functioning well;
• Female and male subjects of childbearing potential should agree to practice contraception during the study and until 6 months after the completion of the study.

You may not qualify if:

• Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;
• Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;
• Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
• Long-term unhealed wounds or fractures
• Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
• A history of psychotropic drug abuse and cannot be abstained, or have a mental disorder;
• Subjects with any severe and/or uncontrolled disease;
• History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
• Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2922 for injection or its excipients;
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.

Sponsors & Collaborators

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

Study Sites (17)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The first affiliated hospital of Guangzhou medical university

Guangzhou, Guangdong, 510062, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Henan Provincine People's Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoming, 116001, China

NOT YET RECRUITING

Department of Medical Oncology, The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 7100614, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

NOT YET RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Li Zhang, Doctor

CONTACT

020-87343458; zhangli@sysucc.org.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: December 19, 2023
• First Posted: January 3, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-03

Locations

CN (17)