Advanced Cancers
Conditions
Brief summary
This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.
Interventions
DRUGTQB2252 injection
TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle.
Sponsors
Chia Tai Tianqing Pharmaceutical (Guangzhou) 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
Yes
Inclusion criteria
* The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance; * 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form); * Electrocorticogram (ECOG) score ranges from 0 to 1 points; * Expected survival is greater than 12 weeks； * Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria； * Late stage malignant tumor subjects who have failed standard treatment or lack effective treatment； * Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; Men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period.
Exclusion criteria
* Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication; * There are multiple factors that affect diseases related to intravenous injection and venous blood collection; * The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1; * Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication; * Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration; * An arterial/venous thrombotic event occurred within 6 months prior to the first administration; * Active viral hepatitis with poor control; * Active syphilis infected individuals in need of treatment; * History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia; * Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; * Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy; * Previously experienced grade 3 or higher adverse reactions related to immunotherapy; * Suffering from significant cardiovascular disease; * Active or uncontrolled severe infections; * Patients with renal failure requiring hemodialysis or peritoneal dialysis; * History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases; * Individuals with epilepsy who require treatment; * Previously received treatment with similar anti-lag3 drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | up to 2 years | Defined as the proportion of subjects with CR, PR, or Stable Disease (SD). |
| Duration of Response (DOR) | up to 2 years | Defined as the time from first documented response to documented disease progression. |
| Time to reach maximum observed plasma concentration (Tmax) | Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days) | Time to reach maximum (peak) plasma concentration following drug administration |
| Progression-free survival (PFS) | up to 2 years | Defined as the time from the first dose of TQB2252 to the first occurrence of disease progression or death from any cause. |
| Elimination half-life (t1/2) | Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days) | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. |
| Objective Response Rate (ORR) | up to 2 years | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria |
| Maximum Plasma Concentration (Cmax) | Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4～Cycle 8: pre-dose. (Each cycle is 21 days) | The Cmax is the maximum observed plasma concentration of TQB2252. |
Countries
China
Contacts
Primary ContactXing Zhang, Doctor
Backup ContactQingqing Cai, Doctor
Outcome results
None listed