Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

Advanced Cancer Clinical Trial

Official title:

A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188624
• Other study ID #: TQB2922-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Li Zhang, Doctor
• Phone: 020-87343458
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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.
Primary	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	Half-life (T1/2)	Terminal half-life (T1/2) after administration	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.
Secondary	The area under the curve (AUC)	The area under the curve (AUC) of blood concentration-time of TQB2922.	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.
Secondary	Apparent plasma clearance (CL)	Apparent plasma clearance of TQB2922.	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.
Secondary	Apparent volume of distribution (Vz)	The ratio of the amount of TQB2922 in the body to the blood concentration	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.
Secondary	Minimum concentration (Cmin)	Minimum observed concentration (Cmin) of TQB2922	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.
Secondary	Objective response rate (ORR)	The percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	Up to 2 years.
Secondary	Duration of response (DOR)	The time from first documented response to documented disease progression.	Up to 2 years.
Secondary	Progression-free survival (PFS)	The time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.	Up to 2 years.
Secondary	Immunogenicity of TQB2922	Immunogenicity of TQB2922 is assessed according to the incidence of anti-drug antibody (ADA).	From the time of informed consent to 90 days after the last dose.