To explore the safety, tolerability and pharmacokinetics of TQB3142 for injection in subjects with advanced malignant tumors
The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
18 years old ≤ age ≤75 years old (calculated on the date of signing the informed consent);
Eastern Cooperative Oncology Group Performance Status (ECOG) score 0~1;
Expected survival greater than 12 weeks;
Any active malignancy within the 3 years prior to the first dose, except for the specific cancer under study in this trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the lamina propria)], carcinoma in situ of the cervix, or carcinoma in situ of the breast).
Failure to recover from toxicities and/or complications of prior interventions to ≤ Grade 1 per CTCAE, except for alopecia and peripheral neuropathy ≤ Grade 2.
Receipt of any blood product transfusion or requirement for hematopoietic growth factor therapy within 28 days prior to the first dose.
Known bleeding diathesis or disorder.
Single group
TQB3142 injection
DrugTQB3142 for injection is a B-cell lymphoma-extra large inhibitor.
Phase II recommended doses (RP2D)
The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).
Dose-limiting toxicity (DLT)
Adverse events that meet the protocol definition of dose-limiting toxic event timing were evaluated according to the Common Terminology Criteria for Adverse Events 5.0.
Maximum tolerated dose (MTD)
The previous dose of the dose group in which dose-limiting toxicity occurs is the maximum tolerated dose.
Numbers of participant with incidence and severity of Adverse Event (AE) and Serious Adverse Event (SAE), and abnormal laboratory test indicators
Numbers of participant with incidence and severity of AE and SAE, and abnormal laboratory test indicators.
Peak time
Time to peak blood concentration after a single dose
Objective response rate
The objective response rate of injection form TQB3142 in patients with advanced solid tumors.
Peak concentration Cmax
After a single dose, the highest point of the drug-time curve is called the peak concentration.
Click on the lead sponsor to view all of their trials.
