Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers

NCT ID: NCT05380882

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-12-31

Brief Summary

TQB2930 is an anti-HER2 (Human Epidermal Growth Factor Receptor 2) bispecific antibody that can simultaneously bind two epitopes of HER2, leading to a dual HER2 signal blockage. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB2930 injection in subjects with advanced malignancies.

Conditions

Advanced Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2930 injection

Drug:Weekly intravenous infusion of TQB2930 injection,21 days as a treatment cycle. (2.5mg/kg, 5mg/kg, 10mg/kg) Drug:Every two weeks intravenous infusion of TQB2930 injection , 28 days as a treatment cycle.(20mg/kg) Drug:Every three weeks intravenous infusion of TQB2930 injection, 21 days as a treatment cycle. (30mg/kg)

Group Type: EXPERIMENTAL

TQB2930 injection

Intervention Type: DRUG

TQB2930 is an anti-HER2 bispecific antibody.

Interventions

TQB2930 injection

TQB2930 is an anti-HER2 bispecific antibody.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• 2 Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
• 3 Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;
• 4 Malignant tumor that failed from standard treatment or had no standard treatment;
• 5 According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
• 6 The main organs function well;
• 7 Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion Criteria

• 1 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years;
• 2 History of uncontrolled intercurrent illness;
• 3 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
• 4 Patients with known symptomatic brain metastases;
• 5 Receiving any other investigational agent within 4 weeks before first dose;
• 6 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruihua Xu, Doctor

Role: CONTACT

ruihxu@163.com

86-20-87343468

Facility Contacts

Ruihua C Xu

Role: primary

ruihxu@163.com

+862087343468

Other Identifiers

TQB2930-I-01

Identifier Type: -

Identifier Source: org_study_id