Clinical trial · Interventional
A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors
NCT06649656CI-TRIAL-00081800not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB2252 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB2252 injection
- description
- This product is administered via intravenous infusion, with recommended doses of 600mg TQB2223 monoclonal antibody and 200mg penpulimab injection, administered once every 3 weeks.
- interventionNames
- Drug: TQB2252 injection
Primary outcomes (1)
- measure
- Adverse events (AE) rate
- timeFrame
- From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.
- description
- 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 outcomes (7)
- measure
- Time to reach maximum observed plasma concentration (Tmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.