Advanced Cancers
Conditions
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.
Interventions
DRUGTQB2930 injection
TQB2930 is an anti-HER2 bispecific antibody.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity (DLT) | At the end of Cycle 1 (each cycle is 21 or 28 days) | 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. |
| Maximum tolerated dose (MTD) | At the end of Cycle 1 (each cycle is 21 or 28 days). | MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. |
| Adverse events (AE) rate | From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first. | The occurrence and severity of all AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: 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 | Terminal half-life (T1/2) |
| Objective Response Rate (ORR) | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria |
| Disease control rate (DCR) | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | Defined as the proportion of subjects with CR, PR, or SD (Stable Disease). |
| immunogenicity | 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) | Incidence of anti-drug antibody (ADA) |
| Progression-free survival (PFS) | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause. |
| Overall survival(OS) | 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 refers to the time from the first treatment to death from any cause. |
| Duration of Response (DOR) | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks | Defined as the time from first documented response to documented disease progression. |
| Pharmacokinetics: The area under the curve (AUC) | 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) | The area under the curve (AUC) of serum concentration of TQB2930 |
| Pharmacokinetics:Peak concentration (Cmax) | 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 | Maximum observed concentration (Cmax) of TQB2930 |
Countries
China
Contacts
Primary ContactRuihua Xu, Doctor
Outcome results
None listed