TQB2922 for injection
DrugTQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle
NCT Number: NCT06188624
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle
Time frame: During the first treatment cycle (28 days).
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.
Time frame: During the first treatment cycle (28 days).
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Time frame: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
The occurrence rate of all AEs during treatment
Time frame: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
The severity of all AEs occured during treatment
Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
Terminal half-life (T1/2) after administration
Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
The area under the curve (AUC) of blood concentration-time of TQB2922.
Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
Apparent plasma clearance of TQB2922.
Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
The ratio of the amount of TQB2922 in the body to the blood concentration
Time frame: Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days.
Minimum observed concentration (Cmin) of TQB2922
Time frame: Up to 2 years.
The percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: Up to 2 years.
The time from first documented response to documented disease progression.
Time frame: Up to 2 years.
The time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.
Time frame: From the time of informed consent to 90 days after the last dose.
Immunogenicity of TQB2922 is assessed according to the incidence of anti-drug antibody (ADA).
Contact information is provided by the study sponsor or research team.
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Industry
A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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