Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study of TQB2930 Injection in Patients With Advanced Cancers

Conditions
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Advanced Cancers

Intervention / Treatment
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* Drug: TQB2930 injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQB2930 injection<br>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) | Drug: TQB2930 injection<br>* TQB2930 is an anti-HER2 bispecific antibody.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicity (DLT) | DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle. | At the end of Cycle 1 (each cycle is 21 or 28 days) | 
| Maximum tolerated dose (MTD) | MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. | At the end of Cycle 1 (each cycle is 21 or 28 days). | 
| Adverse events (AE) rate | The occurrence and severity of all AEs | From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunogenicity | Incidence of anti-drug antibody (ADA) | Cycle 1 Day 1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1: pre-dose and end of the infusion.(each cycle is 21 or 28 days) | 
| Pharmacokinetics: The area under the curve (AUC) | The area under the curve (AUC) of serum concentration of TQB2930 | Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.(21 or 28 days each) | 
| Pharmacokinetics:Peak concentration (Cmax) | Maximum observed concentration (Cmax) of TQB2930 | Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each | 
| Pharmacokinetics: T1/2 | Terminal half-life (T1/2) | Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each | 
| Objective Response Rate (ORR) | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | 
| Disease control rate (DCR) | Defined as the proportion of subjects with CR, PR, or SD (Stable Disease). | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | 
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | 
| Progression-free survival (PFS) | Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | 
| Overall survival(OS) | Overall survival refers to the time from the first treatment to death from any cause. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks |