About this trial
This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily joined this study, signed the informed consent form, and had good compliance;
18-75 yeas old;
Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;
Expected survival of more than 12 weeks;
Disqualifiers
Current concomitant presence of other malignancies within 5 years prior to the first dose;
At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.
Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.
Hyperactive or venous thrombosis events occurred within 6 months before the first administration;
Trial design
Single group
Treatments tested in this trial
TQB2922 injection (subcutaneous injection)
DrugTQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.
Treatment groups
Trial outcomes
Primary outcomes
Time to Peak Concentration
Time to Peak Concentration
Peak concentration
Maximum plasma drug concentration
half-life (T1/2)
Terminal half-life (T1/2)
The area under the curve (AUC0-∞)
The area under the plasma concentration-time curve extrapolated from the first administration to infinity
Secondary outcomes
Adverse Events (AE) rate
The occurrence and severity of all AEs
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
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression.
Progression-free survival (PFS)
Defined as the time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.
Sponsors and contacts
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