Clinical trial · Interventional
Tolerance and Pharmacokinetics of TQB2450
Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection
NCT03460457CI-TRIAL-00031996unknownPhase 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)
To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research.
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 |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB2450 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB2450
- interventionNames
- Drug: TQB2450
Primary outcomes (2)
- measure
- maximum tolerated dose(MTD)
- timeFrame
- 21 days
- measure
- dose-limiting toxicity(DLT)
- timeFrame
- 21 days
Secondary outcomes (6)
- measure
- Peak Plasma Concentration(Cmax)
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced malignancy diagnosed with pathology or cytology who have failed standard treatment or no standard treatment; * 18-70 years old;Eastern Cooperative Oncology Group performance status:0-1,Life expectancy of more than 3 months; * Main organs function is normal; * Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device,contraceptive and condom) throughout treatment and for at least 6 months after study is stopped;the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment,and the patients required to be non-lactating;Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped; * Patients should be voluntary and sign the informed consents before taking part in the study; Exclusion Criteria: * Patients who have received programmed cell death protein 1(PD-1) or programmed cell death protein ligand(PD-L1) antibody treatment; * Patients who had any\> 3 degree immune-related adverse event during any previous immunotherapy received; * Appeared severe hypersensitivity after taking other monoclonal antibody drugs; * Other malignancies have been diagnosed in the past 2 years except cured or locally curable cancers, such as cutaneous or squamous cell carcinoma, superficial bladder cancer, cervical cancer or orthotopic carcinoma of the breast; * Known spinal cord compression, cancer meningitis patients, new onset of central nervous system metastasis or stable control of symptoms in patients with brain metastases less than 4 weeks; asymptomatic and stable imaging without the need for corticosteroid treatment; * Patients with hypothyroidism over 2 degrees; * Patients with active, or who have had, and are likely to relapse, autoimmune diseases; the following patients are enrolled: skin disorders without systemic treatment (eg vitiligo, psoriasis, hair loss); * Patients treated with glucocorticoids or other immunosuppressive agents within 4 weeks prior to dosing; * Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis; * Serious chronic or active infections require systemic antibacterial, antifungal or antiviral treatment (allowing antiviral treatment in patients with hepatocellular carcinoma), including tuberculosis infection; * Unstable pleural effusion, pericardial effusion or ascites; * Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina; * Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history; * Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; * Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C; * The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives; * The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives; * Inoculated with vaccine or attenuated vaccine within 4 weeks before first administration; * Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose;
References
Publications (1)
- DERIVEDXue J, Xue L, Tang W, Ge X, Zhao W, Li Q, Peng W, Dai C, Guo Y, Li J. TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study. Ther Adv Med Oncol. 2024 Jan 6;16:17588359231220516. doi: 10.1177/17588359231220516. eCollection 2024. PMID 38188467