Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers

CTTQ

Status and phase: Unknown; Phase 1

Conditions: Advanced Cancers

Treatments: Drug: TQB2930 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05380882

TQB2930-I-01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

TQB2930 injection

Experimental group

Description:

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)

Treatment:

Drug: TQB2930 injection