About this trial
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily join this study, sign the informed consent form, and have good compliance;
Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months;
Histologically or cytologically diagnosed with advanced cancers;
Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;
Disqualifiers
Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;
Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;
Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
Long-term unhealed wounds or fractures
Trial design
Single group
Treatments tested in this trial
TQB2922 for injection
DrugTQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle
Treatment groups
Trial outcomes
Primary outcomes
Dose limiting toxicity (DLT)
DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred.
Maximum tolerated dose (MTD)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Adverse events (AEs) rate
The occurrence rate of all AEs during treatment
Adverse events (AEs) severity
The severity of all AEs occured during treatment
Secondary outcomes
Half-life (T1/2)
Terminal half-life (T1/2) after administration
The area under the curve (AUC)
The area under the curve (AUC) of blood concentration-time of TQB2922.
Apparent plasma clearance (CL)
Apparent plasma clearance of TQB2922.
Apparent volume of distribution (Vz)
The ratio of the amount of TQB2922 in the body to the blood concentration
Sponsors and contacts
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